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27Mar

Portable Oxygen Concentrators Market Analysis, Scope, Trends and Report 2024-2032

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IMARC Group’s report titled “Portable Oxygen Concentrators Market Report by Technology (Continuous Flow, Pulse Flow), Application (Chronic Obstructive Pulmonary Disease (COPD), Asthma, Respiratory Distress Syndrome, Sleep Apnea, and Others), End User (Hospitals, Ambulatory Surgery Centers, and Others), and Region 2024-2032”. The global portable oxygen concentrators market size reached US$ 1.8 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 3.4 Billion by 2032, exhibiting a growth rate (CAGR) of 7.3% during 2024-2032.

For an in-depth analysis, you can refer sample copy of the report: www.imarcgroup.com/portable-oxygen-concentrators-market/requestsample

Factors Affecting the Growth of the Portable Oxygen Concentrators Industry:

  • Increasing Prevalence of Respiratory Diseases:

The rising number of individuals suffering from respiratory conditions, such as chronic obstructive pulmonary disease (COPD), asthma, and sleep apnea, is supporting the growth of the market. These conditions often necessitate oxygen therapy to improve breathing and overall health. The global population is aging, and elderly individuals are more susceptible to respiratory diseases. The growing number of individuals who require oxygen therapy to manage their conditions is offering a favorable market outlook. Portable oxygen concentrators offer a convenient solution for these patients. Advancements in medical diagnostics and increased awareness of respiratory health are leading to earlier and more accurate diagnoses.

Individuals are becoming more susceptible to respiratory conditions, such as chronic obstructive pulmonary disease (COPD), pneumonia, and obstructive sleep apnea. These conditions often necessitate oxygen therapy. As the elderly population is growing, the number of individuals requiring oxygen support. Aging is often accompanied by the development of multiple chronic health conditions. Many elderly individuals have comorbidities that can exacerbate respiratory issues, making oxygen therapy crucial for their overall well-being. Elderly individuals prefer to receive medical care in the comfort of their homes whenever possible.

  • Advancements in Technology:

Technological innovations are making it possible to design smaller and lighter portable oxygen concentrators. This reduction in size and weight is significantly improving the portability of these devices, allowing patients greater freedom of movement. Modern portable oxygen concentrators feature advanced battery technology that provides longer operational hours on a single charge. This extended battery life enables patients to use the device for an extended period without needing frequent recharges.

Leading Companies Operating in the Global Portable Oxygen Concentrators Industry:

  • Caire Inc. (NGK Spark Plug Co. Ltd)
  • Chart Industries Inc.
  • Drive Devilbiss Healthcare Limited (Drive International LLC)
  • Inogen Inc.
  • Invacare Corporation
  • Koninklijke Philips N.V
  • Nidek Medical India Pvt Ltd
  • O2 Concepts LLC
  • Precision Medical Inc. (BioHorizons Inc.)
  • Resmed Inc.
  • Teijin Limited

Portable Oxygen Concentrators Market Report Segmentation:

By Technology:

  • Continuous Flow
  • Pulse Flow

Pulse flow represents the largest segment as it offers a more efficient and tailored oxygen delivery method for patients with varying respiratory needs.

By Application:

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Asthma
  • Respiratory Distress Syndrome
  • Sleep Apnea
  • Others

Chronic obstructive pulmonary disease (COPD) accounts for the largest market share due to its reliance on long-term oxygen therapy.

By End User:

  • Hospitals
  • Ambulatory Surgery Centers
  • Others

Ambulatory surgery centers hold the biggest market share as they frequently require portable oxygen concentrators to support patients during outpatient procedures and surgeries.

Regional Insights:

  • North America (United States, Canada)
  • Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, Others)
  • Europe (Germany, France, United Kingdom, Italy, Spain, Russia, Others)
  • Latin America (Brazil, Mexico, Others)
  • Middle East and Africa

North America enjoys the leading position in the portable oxygen concentrators market due to a large aging population and high prevalence of respiratory diseases.

Global Portable Oxygen Concentrators Market Trends:

The aging population is catalyzing the demand for portable oxygen concentrators. As the elderly population is growing, there is a higher prevalence of respiratory conditions, making these devices essential for managing health and improving the quality of life.

Ongoing technological innovations are leading to smaller, lighter, and more efficient portable oxygen concentrators. These advancements enhance device portability, battery life, and user-friendliness, making them more appealing to patients.

Note: If you need specific information that is not currently within the scope of the report, we will provide it to you as a part of the customization.

About Us:

IMARC Group is a leading market research company that offers management strategy and market research worldwide. We partner with clients in all sectors and regions to identify their highest-value opportunities, address their most critical challenges, and transform their businesses.

IMARCs information products include major market, scientific, economic and technological developments for business leaders in pharmaceutical, industrial, and high technology organizations. Market forecasts and industry analysis for biotechnology, advanced materials, pharmaceuticals, food and beverage, travel and tourism, nanotechnology and novel processing methods are at the top of the company’s expertise.

Our offerings include comprehensive market intelligence in the form of research reports, production cost reports, feasibility studies, and consulting services. Our team, which includes experienced researchers and analysts from various industries, is dedicated to providing high-quality data and insights to our clientele, ranging from small and medium businesses to Fortune 1000 corporations.

Contact US:

IMARC Group

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Email: sales@imarcgroup.com

Tel No:(D) +91 120 433 0800

United States: +1-631-791-1145 | United Kingdom: +44-753-713-2163



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27Mar

Inhaled Nitric Oxide Market Projected to Reach $1,157.38 million by 2030

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PUNE, India, March 27, 2024 /PRNewswire/ -- The report titled "Inhaled Nitric Oxide Market by Application (Acute Respiratory Distress Syndrome, Chronic Obstructive Pulmonary Disease, Malaria Treatment), End-Users (Clinic, Hospital) - Global Forecast 2024-2030" is now available on 360iResearch.com's offering, presents an analysis indicating that the market projected to grow from a size of $778.21 million in 2023 to reach $1,157.38 million by 2030, at a CAGR of 5.83% over the forecast period.

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"Expanding Boundaries Revolutionizing Respiratory Care Using Inhaled Nitric Oxide Globally"

Using inhaled nitric oxide in intensive care is a significant therapy, primarily benefiting newborns and children suffering from severe pulmonary conditions such as persistent pulmonary hypertension of the newborn (PPHN) and acute respiratory distress syndrome (ARDS). This innovative treatment, delivered directly to the lungs, effectively enhances oxygenation without influencing blood pressure elsewhere, marking a significant stride in medical care. Its application has broadened beyond hospital settings to include home care, thereby promising a better quality of life for patients as the incidence of conditions treated by inhaled nitric oxide rises with technological advancements in portable delivery systems. Nonetheless, the market faces challenges due to the high costs and rigorous regulatory standards governing its use. The continued research into new therapeutic uses and improvements in delivery technology are setting the stage for more accessible and cost-effective treatments. Globally, inhaled nitric oxide is gaining traction, especially in the Americas, driven by a high rate of respiratory illnesses and a robust healthcare infrastructure. Europe is witnessing a growing demand, backed by innovation and robust regulatory frameworks, whereas the Asia-Pacific region is rapidly adopting this therapy, fueled by healthcare advancements and an increasing awareness of cutting-edge treatments.

Download Sample Report @ www.360iresearch.com/library/intelligence/inhaled-nitric-oxide

"Enhancing Respiratory Care: The Increasing Role of Inhaled Nitric Oxide Amid Rising Respiratory Disorders"

The medical community is turning toward innovative treatments such as inhaled nitric oxide (iNO)owing to the global increase in respiratory diseases, such as chronic obstructive pulmonary disease (COPD), the ongoing impacts of conditions such as acute respiratory distress syndrome (ARDS), and the long-term effects of COVID-19. Renowned for improving oxygenation in the lungs through vasodilation, iNO therapy is a groundbreaking solution in treating various respiratory issues, including pulmonary hypertension and ARDS. Its role in enhancing lung function while reducing reliance on mechanical ventilation is particularly notable in neonatal care, where it offers hope for premature infants facing hypoxic respiratory failure. The adoption of iNO in healthcare settings is gaining pace as respiratory disorders continue to affect millions globally due to respiratory illness. This treatment's integration into patient care routines highlights a critical advancement in addressing the urgent need for effective, non-invasive therapies, driving improvements in respiratory health and patient recovery rates.

"Revolutionizing Respiratory Care: The Expanding Role of Inhaled Nitric Oxide"

Inhaled nitric oxide (iNO) is a treatment crucial in managing various respiratory conditions by enhancing oxygenation and easing pulmonary arterial pressures. Its capability to dilate lung blood vessels offers significant benefits, particularly for chronic obstructive pulmonary disease (COPD) patients. These individuals often face severe flare-ups that worsen their breathing difficulties. iNO offers expectancy during critical times, potentially improving gas exchange and lessening the effects of pulmonary hypertension. Emerging research highlights iNO's potential in combating severe malaria, owing to its inflammation-reducing capabilities and improvement in blood flow. Furthermore, its established success in treating newborns with hypoxic respiratory failure highlights its life-saving impact. Additionally, exploring iNO in treating tuberculosis opens a new frontier, especially for combating drug-resistant strains, showcasing its versatility and potential as an adjunctive therapy. This multipurpose application of inhaled nitric oxide highlights its pivotal role in advancing respiratory care and offering hope to patients across a spectrum of conditions.

Request Analyst Support @ www.360iresearch.com/library/intelligence/inhaled-nitric-oxide

"Merck KGaA at the Forefront of Inhaled Nitric Oxide Market with a Strong 11.95% Market Share"

The key players in the Inhaled Nitric Oxide Market include VERO Biotech Inc., Getinge AB, Air Liquide SA, Merck KGaA, GE HealthCare Technologies, Inc., and others. These prominent players focus on strategies such as expansions, acquisitions, joint ventures, and developing new products to strengthen their market positions.

"Introducing ThinkMi: Revolutionizing Market Intelligence with AI-Powered Insights for the Inhaled Nitric Oxide Market"

We proudly unveil ThinkMi, a cutting-edge AI product designed to transform how businesses interact with the Inhaled Nitric Oxide Market. ThinkMi stands out as your premier market intelligence partner, delivering unparalleled insights with the power of artificial intelligence. Whether deciphering market trends or offering actionable intelligence, ThinkMi is engineered to provide precise, relevant answers to your most critical business questions. This revolutionary tool is more than just an information source; it's a strategic asset that empowers your decision-making with up-to-the-minute data, ensuring you stay ahead in the fiercely competitive Inhaled Nitric Oxide Market. Embrace the future of market analysis with ThinkMi, where informed decisions lead to remarkable growth.

Ask Question to ThinkMi @ app.360iresearch.com/library/intelligence/inhaled-nitric-oxide

"Dive into the Inhaled Nitric Oxide Market Landscape: Explore 180 Pages of Insights, 198 Tables, and 20 Figures"

  1. Preface

  2. Research Methodology

  3. Executive Summary

  4. Market Overview

  5. Market Insights

  6. Inhaled Nitric Oxide Market, by Application

  7. Inhaled Nitric Oxide Market, by End-Users

  8. Americas Inhaled Nitric Oxide Market

  9. Asia-Pacific Inhaled Nitric Oxide Market

  10. Europe, Middle East & Africa Inhaled Nitric Oxide Market

  11. Competitive Landscape

  12. Competitive Portfolio

Inquire Before Buying @ www.360iresearch.com/library/intelligence/inhaled-nitric-oxide

Related Reports:

  1. Inhaled Nitric Oxide Delivery Systems Market - Global Forecast 2024-2030

  2. Medical Nitrous Oxide Market - Global Forecast 2024-2030

  3. Concentrated Nitric Acid Market - Global Forecast 2024-2030

About 360iResearch

Founded in 2017, 360iResearch is a market research and business consulting company headquartered in India, with clients and focus markets spanning the globe.

We are a dynamic, nimble company that believes in carving ambitious, purposeful goals and achieving them with the backing of our greatest asset — our people.

Quick on our feet, we have our ear to the ground when it comes to market intelligence and volatility. Our market intelligence is diligent, real-time and tailored to your needs, and arms you with all the insight that empowers strategic decision-making.

Our clientele encompasses about 80% of the Fortune Global 500, and leading consulting and research companies and academic institutions that rely on our expertise in compiling data in niche markets. Our meta-insights are intelligent, impactful and infinite, and translate into actionable data that support your quest for enhanced profitability, tapping into niche markets, and exploring new revenue opportunities.

Contact 360iResearch

Mr. Ketan Rohom
360iResearch Private Limited,
Office No. 519, Nyati Empress,
Opposite Phoenix Market City,
Vimannagar, Pune, Maharashtra,
India - 411014.
Email: sales@360iresearch.com
USA: +1-530-264-8485
India: +91-922-607-7550

To learn more, visit 360iresearch.com or follow us on LinkedIn, Twitter, and Facebook.

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27Mar

Respiratory Care Device Market Projected to Reach USD 38.55 Billion by 2030 Driven by CAGR of 8.9%

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The global respiratory care device market is poised for significant growth owing to the rising prevalence of respiratory diseases and increasing awareness about respiratory health.

The SNS Insider report indicates that the Respiratory Care Device Market Size was valued at USD 19.49 Billion in 2022 and is expected to reach USD 38.55 Billion by 2030, growing at a CAGR of 8.9% over the forecast period 2023-2030.

Market report Scope

Respiratory Care Devices are utilized for analysis, monitoring, and therapy of respiratory infections like Chronic Obstructive Pulmonary Disease (COPD), asthma, tuberculosis, and pneumonia. These devices provide improved care to patients experiencing such acute and chronic respiratory illnesses.

The report analyses the respiratory care devices market based on product type, end-user, and geography. As the world's population ages and environmental factors affect respiratory health, there is a growing demand for respiratory care equipment.

These medical supplies and apparatus help patients control respiratory conditions or provide breathing support when required. They are used in various healthcare settings, including clinics, hospitals, and home care settings.

Market Analysis:

Demand for respiratory care is driven by infectious respiratory diseases, which have increased during the pandemic, boosting the market. Government and non-profit initiatives like the global initiative for asthma (GINA) and awareness campaigns have also contributed to market growth.

Moreover, the increase in the geriatric population and the rising prevalence of respiratory diseases further accelerate market expansion.

Get Free Sample Copy of Report: www.snsinsider.com/sample-request/1072

Major Key Players in Respiratory Care Device Market:

  • Koninklijke Philips N.V.

  • ResMed

  • Medtronic

  • Fisher and Paykel Healthcare Limited

  • BD

  • Chart Industries Inc.

  • Drägerwerk

  • AG & Co. KGaA

  • Hamilton Medical

  • Teleflex Incorporated

  • 3M

Key Segments Covered in Report:

By Product:

  • Therapeutic Devices                

  • Monitoring Devices        

  • Diagnostic Devices

  • Consumables and Accessories

By Indication:

  • Chronic Obstructive Pulmonary Disease (COPD)             

  • Asthma              

  • Sleep Apnea

  • Infectious Disease        

  • Others

By End-User

  • Hospitals    

  • Home Care Settings

  • Ambulatory Care Centers

  • Others

Segment Analysis:

By disease indication, the COPD segment dominates due to factors such as tobacco smoking, indoor/outdoor air pollution, and exposure to dust and chemicals, which contribute to COPD's prevalence.

By end users, home care settings are witnessing rapid growth, especially in sleep apnea therapeutics, driven by the convenience they offer to patients.

Ask For Discount: www.snsinsider.com/discount/1072

Regional Development:

North America leads the respiratory care devices market due to the high prevalence of respiratory illnesses like COPD. In contrast, the Asia-Pacific region is growing significantly due to a large pool of respiratory patients, air pollution, and the rise in tobacco smoking.

Additionally, APAC's development as a medical tourism hub attracts patients due to lower costs and the availability of skilled medical professionals.

Key Takeaways:

The respiratory care device market is on a trajectory to reach USD 38.55 billion by 2030, fueled by rising respiratory diseases and increased awareness.

COPD and home care settings are dominant segments, driven by factors like tobacco smoking and patient convenience.

North America and Asia-Pacific lead in market size and growth, respectively, due to disease prevalence and healthcare infrastructure.

Recent Developments:

In July 2022, Smile Train, Inc. and Lifebox partnered to launch the Lifebox-Smile Train pulse oximeter, expanding access to critical care tools.

Omron Healthcare also introduced a portable oxygen concentrator, a breakthrough in oxygen therapy for continuous high-purity oxygen supply.

Respiratory Care Device Market Report: www.snsinsider.com/checkout/1072

Table of Content

Chapter 1 Introduction 

Chapter 2 Research Methodology

Chapter 3 Respiratory Care Device Market Dynamics

Chapter 4 Impact Analysis (COVID-19, Ukraine- Russia war, Ongoing Recession on Major Economies)

Chapter 5 Value Chain Analysis

Chapter 6 Porter’s 5 forces model

Chapter 7 PEST Analysis

Chapter 8 Respiratory Care Device Market Segmentation, By Product

Chapter 9 Respiratory Care Device Market Segmentation, By Indication

Chapter 10 Respiratory Care Device Market Segmentation, By End-User

Chapter 11 Regional Analysis

Chapter 12 Company profile

Chapter 13 Competitive Landscape

Chapter 14 Use Case and Best Practices

Chapter 15 Conclusion

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Category: Industry Reports & Market Analysis Profile: In the fast-paced business biospheres, businesses need to constantly evolve to grow and stay relevant. At SNS Insider, we believe in adopting a data-oriented approach to aid organizations be familiar with the nerve of the industry.

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27Mar

Moderna Advances Multiple Vaccine Programs to Late-Stage Clinical Trials

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  • Announces next-generation COVID-19 vaccine candidate as fourth respiratory vaccine to successfully meet its Phase 3 endpoints
  • Expects two more Phase 3 readouts in 2024, including combination vaccine against flu and COVID-19, and vaccine against CMV
  • Announces positive clinical trial data from three new vaccines against viruses that cause significant burden (Epstein-Barr virus, Varicella-Zoster virus, norovirus) and advances programs toward Phase 3 development
  • Anticipates U.S. launch of vaccine against RSV following FDA approval and ACIP recommendation in 2024
  • Announces development and commercialization funding agreement with Blackstone Life Sciences for up to $750 million to advance flu program

CAMBRIDGE, MA / ACCESSWIRE / March 27, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced at its fifth Vaccines Day event clinical and program updates demonstrating advancement and acceleration of its mRNA pipeline. The updates include data readouts in the Company's respiratory and latent and other vaccine portfolios, as well as commercial, manufacturing and financial announcements for its vaccines business.

"Our mRNA platform continues a remarkable track record across our broad vaccine portfolio. Today, we are excited to share that four vaccines in our pipeline have achieved successful clinical readouts across our respiratory, latent and other virus franchises," said Stéphane Bancel, Chief Executive Officer of Moderna. "With five vaccines in Phase 3, and three more moving toward Phase 3, we have built a very large and diverse portfolio addressing significant unmet medical needs. We are focused on execution to further build momentum across our pipeline and business, and to deliver for patients who are impacted by these infectious diseases."

Portfolio Overview

The vaccine portfolio seeks to address infectious diseases that cause considerable health burdens and includes 28 vaccines addressing respiratory, latent and other pathogens.

Latent and Other Vaccine Portfolio

Moderna is advancing five vaccine candidates against viruses that cause latent infections, all of which are in clinical trials. When latent, a virus is present in the body but exists in a resting state, typically without causing any noticeable symptoms. Latent viruses can reactivate and cause clinical symptoms as a person ages, during times of stress or when immunity is compromised. The capacity for latency is a defining feature of members of the Herpesviridae family, including cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus (HSV) and Varicella-Zoster virus (VZV).

Cytomegalovirus (CMV)

CMV is the most common infectious cause of birth defects in the U.S. and is responsible for several billion dollars in annual healthcare costs. One in 200 babies in the U.S. are born with a congenital CMV infection, and of those affected, one in five will have severe, life-altering health problems. Possible short- and long-term sequelae of CMV infection include microcephaly, chorioretinitis, seizures, sensorineural hearing loss, cognitive impairment and cerebral palsy. There is currently no approved vaccine to prevent congenital CMV.

CMVictory is a pivotal Phase 3 trial evaluating mRNA-1647 against primary CMV infection in women 16 to 40 years of age. The trial is a randomized, observer-blind, placebo-controlled study designed to evaluate the efficacy, safety and immunogenicity of mRNA-1647. The trial is fully enrolled with approximately 7,300 participants from 290 clinical sites globally.

To date, 50 primary infection cases have accrued and are undergoing confirmation. The first interim analysis for the evaluation of vaccine efficacy, which will be triggered when both 81 confirmed per-protocol cases and 12 median months of safety follow-up have occurred, is expected as early as the end of 2024.

Moderna's CMV vaccine candidate mRNA-1647 has advanced to indication expansion studies in adolescents 9 to 15 years of age and adult transplant patients, both of which have begun enrollment.

Epstein-Barr virus (EBV)

EBV is a major cause of infectious mononucleosis (IM) in the U.S., accounting for more than 90% of IM cases annually. Importantly, EBV and IM are associated with a higher lifetime risk of more serious sequelae including certain cancers such as gastric carcinoma, nasopharyngeal carcinoma and multiple types of lymphoma. The lifetime risk of developing multiple sclerosis (MS) is increased by 32-fold after EBV infection. There is currently no approved vaccine to prevent EBV.

Moderna's EBV vaccine candidates are designed to tackle multiple EBV-associated conditions, including prevention of IM (mRNA-1189) and MS and post-transplant lymphoproliferative disorder, a subcategory of lymphoma in solid organ transplant patients (mRNA-1195). The Phase 1 trial for mRNA-1189 was designed to test the safety, reactogenicity and immunogenicity of four different dose levels in participants 12 to 30 years of age in the U.S. The randomized, observer-blind, placebo-controlled study showed mRNA-1189 was immunogenic and generally well tolerated across all dose levels. The Company is advancing mRNA-1189 toward a pivotal Phase 3 trial.

The Phase 1 trial for mRNA-1195 was designed to test the safety, reactogenicity and immunogenicity of two drug products at four different dose levels in healthy EBV seropositive participants 18 to 55 years of age in the U.S. The randomized, observer-blind, placebo-controlled study is fully enrolled.

Herpes simplex virus (HSV)

Herpes simplex virus type 2 (HSV-2) infects approximately 13% of adults globally and is the primary cause of genital herpes. There are an estimated four billion people globally infected with HSV, of which 491 million cases are HSV-2. Recurrent genital herpes causes a reduction in quality of life, which antivirals (current standard of care) only partially restore. Moderna expects that if an HSV vaccine candidate could deliver similar efficacy as a suppressive antiviral treatment, compliance with recommended therapy and associated quality of life would improve. There is currently no approved vaccine to treat HSV-2.

The first in human, fully enrolled Phase 1/2 trial of mRNA-1608 is designed to test safety and immunogenicity and to establish a proof-of-concept of clinical benefit in adults 18 to 55 years of age with recurrent HSV-2 genital herpes. The randomized 1:1:1:1, observer-blind, controlled study is fully enrolled with 300 participants in the U.S.

Varicella-Zoster virus (VZV)

Herpes zoster, also known as shingles, is caused by reactivation of latent VZV, the same virus that causes chickenpox. Declining immunity in older adults decreases immunity against VZV, allowing reactivation of the virus from latently infected neurons, causing painful and itchy lesions. Herpes Zoster occurs in one out of three adults in the U.S. in their lifetime and the incidence increases at 50 years of age. There is potential to reach a growing and underserved patient population.

Moderna's VZV vaccine candidate mRNA-1468 has initial data available from a Phase 1/2 trial, which was designed to test safety and immunogenicity in healthy adults 50 years of age and older in the U.S. The randomized 1:1:1:1:1, observer-blind, active-controlled study of mRNA-1468 elicited strong antigen-specific T cell responses at one month after the second dose and was generally well tolerated. Results of the first interim analysis support the further clinical development of mRNA-1468 for the prevention of shingles. Additional results from the ongoing Phase 1/2 study will be available later this year, including persistence data. The Company is planning for a pivotal Phase 3 trial.

Norovirus

Enteric viruses, including norovirus, are a leading cause of diarrheal diseases, resulting in significant morbidity and mortality worldwide, particularly among young children and older adults. Norovirus is highly contagious and a leading cause of diarrheal disease globally, associated with 18% of all acute gastroenteritis (AGE), resulting in approximately 200,000 deaths per year and substantial healthcare costs. Given the wide diversity of norovirus genotypes, a broadly effective norovirus vaccine will require a multivalent vaccine design. There is currently no approved vaccine to prevent norovirus.

The randomized, observer-blind, placebo-controlled Phase 1 trial was designed to evaluate the safety, reactogenicity and immunogenicity of trivalent (mRNA-1403) and pentavalent (mRNA-1405) norovirus vaccine candidates in 664 participants 18 to 49 years of age and 60 to 80 years of age in the U.S. An interim analysis showed that a single dose of mRNA-1403 elicited a robust immune response across all dose levels evaluated with a clinically acceptable reactogenicity and safety profile. The Company is advancing mRNA-1403 toward a pivotal Phase 3 trial.

Respiratory Vaccine Portfolio

Moderna's approach to ease the global burden of respiratory infections includes vaccine candidates against major causative pathogens, including SARS-CoV-2, respiratory syncytial virus (RSV) and influenza virus. Respiratory infections are a top cause of death in the U.S. and are particularly harmful to the young, immunocompromised, and older adults who experience more severe illness, greater incidence of hospitalization, and greater mortality than younger adults.

Moderna's respiratory pipeline includes Phase 3 trials for investigational vaccines including a next-generation COVID-19 vaccine, an RSV vaccine, a flu vaccine, and a flu and COVID-19 combination vaccine. The pipeline includes three additional flu vaccine candidates with expanded antigen coverage as well as combination vaccine programs.

COVID-19

Moderna continues to address the needs of the endemic COVID-19 market by focusing on public health efforts to increase vaccination coverage rates to reduce the substantial burden of COVID-19 as well as by advancing next-generation vaccines. The Company's mRNA platform can produce variant-matched vaccines on an accelerated time horizon, consistent with recent U.S. Food and Drug Administration (FDA) comments on the timing of potential strain selection for the fall booster season.

A recent announcement of positive interim results from the NEXTCove Phase 3 trial showed that mRNA-1283 elicited a higher immune response against both the Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2 compared to mRNA-1273.222, Moderna's licensed COVID-19 vaccine. mRNA-1283 is designed to be refrigerator-stable and paves the way for a combination vaccine against influenza and COVID-19, mRNA-1083, enhancing the Company's overall respiratory portfolio. This is Moderna's fourth infectious disease vaccine program with Phase 3 data.

Respiratory Syncytial Virus (RSV)

RSV is the leading cause of respiratory illness in young children, and older adults are at increased risk relative to younger adults for severe outcomes. In addition to acute mortality and morbidity, RSV infection is associated with long-term sequelae such as asthma and impaired lung function in pediatric populations, and exacerbation of chronic obstructive pulmonary disease in older adults. Annually, there are approximately two million medically attended RSV infections and 58,000 to 80,000 hospitalizations in children younger than five years old in the U.S. In the U.S., each year there are up to 160,000 hospitalizations and 10,000 deaths in adults 65 years and older due to RSV. Across high-income countries in 2019, RSV caused an estimated 5.2 million cases, 470,000 hospitalizations and 33,000 in-hospital deaths in adults 60 years and older.

mRNA-1345

Moderna's RSV vaccine candidate, mRNA-1345, is in an ongoing Phase 2/3, randomized, observer-blind, placebo-controlled case-driven trial (ConquerRSV) in adults over 60 years of age. In this study, approximately 37,000 participants from 22 countries were randomized 1:1 to receive one dose of mRNA-1345 or placebo.

Based on positive data from the ConquerRSV trial, Moderna has filed for regulatory approvals for mRNA-1345 for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults over 60 years of age.

The trial met both its primary efficacy endpoints, with a vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-LRTD as defined by two or more symptoms, and a VE of 82.4% (96.36% CI: 34.8%, 95.3%; p=0.0078) against RSV-LRTD defined by three or more symptoms. These data were published in the New England Journal of Medicine in December 2023.

A subsequent analysis from the ConquerRSV study with a longer median follow-up duration of 8.6 months (versus 3.7 months in the primary analysis), with a range of 15 days to 530 days, and including subjects from the Northern and Southern Hemispheres was recently presented at the RSVVW'24 conference. In this supplemental analysis, mRNA-1345 maintained durable efficacy, with sustained VE of 63.3% (95.88% CI: 48.7%, 73.7%) against RSV-LRTD including two or more symptoms. VE was 74.6% (95% CI: 50.7%, 86.9%) against RSV-LRTD with ≥2 symptoms, including shortness of breath and 63.0% (95% CI: 37.3%, 78.2%) against RSV-LRTD including three of more symptoms. The stringent statistical criterion of the study, a lower bound on the 95% CI of >20%, continued to be met for both endpoints.

mRNA-1345 has been granted Breakthrough Therapy designation by the FDA for the prevention of RSV-LRTD in adults over 60 years of age. The Company is awaiting regulatory approvals and the U.S. ACIP recommendation in 2024.

Indication expansion studies for mRNA-1345

mRNA-1345 has the potential to protect all vulnerable populations from RSV. Moderna has initiated multiple Phase 3 expansion studies in adults over 50 years of age to evaluate co-administration and revaccination. Additional trials (Phase 1 - Phase 3) have been initiated for high-risk adults, as well as maternal and pediatric populations. Interim data from these studies could be available as early as 2024.

Influenza (Flu)

Worldwide, influenza leads to 3-5 million severe cases of flu and 290,000-650,000 flu-related respiratory deaths annually. Two main types of influenza viruses (A and B) cause seasonal flu epidemics, and the influenza A viruses lead to most flu-related hospitalization in older adults.

The Company has several seasonal influenza vaccine candidates in clinical development. Moderna's seasonal flu vaccine, mRNA-1010, demonstrated consistently acceptable safety and tolerability across three Phase 3 trials. In the most recent Phase 3 trial (P303), which was designed to test the immunogenicity and safety of an optimized vaccine composition, mRNA-1010 met all immunogenicity primary endpoints, demonstrating higher antibody titers compared to a currently licensed standard-dose flu vaccine. In an older adult extension study of P303, mRNA-1010 is being studied against high dose Fluzone HD®; the trial is fully enrolled. The Company is in ongoing discussions with regulators and intends to file in 2024.

Combination Respiratory Vaccines

Moderna's combination vaccine candidates cover respiratory viruses associated with the largest disease burden in the category. The Phase 3 combination study of the Company's investigational combination vaccine against flu and COVID-19 (mRNA-1083) for adults aged 50 years and older is fully enrolled and data are expected in 2024. mRNA-1083 was granted Fast Track designation by the FDA in May 2023.

Commercial Updates

Respiratory viruses in addition to latent and other viruses represent large unmet or underserved medical needs, and the human and economic costs from these infectious diseases highlight the need for effective vaccines. To help address this need, Moderna expects multiple vaccine product launches in the next few years, each with significant addressable markets.

The 2024 global endemic COVID-19 vaccine market alone is estimated by Moderna to be approximately $10 billion. COVID-19 continues to show a high burden of disease, and while COVID-19 hospitalizations remain high relative to RSV and flu, the risks of Long COVID are also becoming better understood. Moderna is focused on improving education and awareness to increase vaccination rates as Long COVID data suggests even traditionally low-risk groups should be vaccinated. Moderna is also working with health authorities to align the timing of COVID-19 and flu vaccine launches to help improve public health.

For RSV, Moderna estimates the peak annual market to be approximately $10 billion. The Company expects a strong RSV vaccine launch into a large market in 2024. As the only mRNA investigational vaccine with positive Phase 3 data, Moderna's RSV vaccine candidate has a strong profile with consistently strong efficacy across vulnerable and older populations, a well-established safety and tolerability profile, and ease of administration with a ready-to-use, pre-filled syringe formulation, which could relieve some of the burden that falls on pharmacies during the fall vaccination season.

An interim analysis from an ongoing time and motion study evaluating differences in preparation time between a pre-filled syringe (PFS) presentation and vaccines that require reconstitution showed that a PFS presentation could relieve some of the burden that falls on pharmacies during the fall vaccination season. Results from this study suggest that pharmacies may be capable of preparing up to four times as many doses of PFS in an hour compared to vaccines requiring reconstitution.

Moderna estimates flu vaccines represent an approximately $7 billion market in 2024. The market is expected to grow with the rise of more effective vaccines and there is an opportunity to expand the market with next-generation premium flu vaccines as well as combination respiratory vaccines, adding increased value to the health ecosystem.

CMV is expected to be a $2-5 billion annual market. With no vaccine currently on the market and a potential vaccine launch in 2026, Moderna could be the first CMV vaccine in multi-billion-dollar latent vaccine market. In addition, EBV has the potential to address and reduce the burden and cost of EBV infection in multiple populations, while VZV provides the opportunity to enter a large and growing market, which could be $5-6 billion annually. The market for norovirus vaccines is similar to that of rotavirus in pediatrics with opportunity to expand into the adult population, and represents a $3-6 billion annual market.

Moderna's vaccine portfolio targets large addressable markets, with an estimated total addressable market (TAM) of $52 billon for Moderna infectious disease vaccines, which includes a respiratory vaccines TAM of more than $27 billion and a latent and other vaccines TAM of more than $25 billion.

Manufacturing

The Company's manufacturing innovation supports expanding commercialization of a diverse pipeline through efficiency and productivity gains. Its mRNA manufacturing platform enables benefits such as quality, speed, scale and cost efficiency across a footprint that broadly includes the manufacture of plasmid, mRNA, lipid nanoparticles, as well as fill/finish and quality control capabilities.

As the Company continues to build its footprint for the future, it is developing an agile global manufacturing network to meet commercial demand and support its growing pipeline. Pre-clinical through commercial manufacturing occurs at the Moderna Technology Center in Norwood, Massachusetts, which remains central to the Company's network. New facilities being constructed in Australia, Canada and the UK are expected to come online in 2025, and drug product capacity is achieved through a flexible contract manufacturing network. Additionally, the Company has purchased and started build-out of a manufacturing site in Marlborough, Massachusetts, to enable commercial scale of its individualized neoantigen therapy program.

By continuing to pioneer new technologies, including advanced robotics, applying AI and other digital solutions, and driving network and capital efficiency, Moderna's manufacturing network is expected to also drive more predictable cost of sales.

Research and Development Investment Strategy

Today's updates provide further evidence that Moderna's mRNA technology platform is working, and with a rate of success higher than industry standard. Looking ahead, research and development will continue to be the Company's top capital allocation priority.

As Moderna looks to create value through the research and development strategy for its vaccine portfolio, it is taking three prioritization parameters into consideration: pipeline advancement, revenue diversification and risk reduction. As part of its strategy, the funding options Moderna considers are self-funding, project financing and partnerships.

Moderna recently entered into a development and commercialization funding agreement with Blackstone Life Sciences to advance the Company's flu program. As part of the agreement, Blackstone will fund up to $750 million with a return based on cumulative commercial milestones and low-single digit royalties. Moderna expects to recognize the funding as a reduction in research and development expenses and will retain full rights and control of the Company's flu program. This funding does not result in any change to Moderna's 2024 research and development framework of approximately $4.5 billion.

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.


Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

INDICATION (U.S.)

SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

IMPORTANT SAFETY INFORMATION

  • Do not administer to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
  • Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.
  • Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age.
  • Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
  • Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the vaccine.
  • The vaccine may not protect all vaccine recipients.
  • Adverse reactions reported in clinical trials following administration of the vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site, and rash.
  • The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.
  • Please see the SPIKEVAX Full Prescribing Information. For information regarding authorized emergency uses of the Moderna COVID-19 Vaccine, please see the EUA Fact Sheet.

Spikevax® is a registered trademark of Moderna.
Fluzone® is a registered trademark of Sanofi Pasteur.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the advancement of Moderna's programs under clinical development; the timing for anticipated approvals of vaccine candidates; the efficacy, safety and tolerability of vaccine candidates; the total addressable markets for programs under development; the efficiencies and advantages of Moderna's mRNA platform; future capital allocation and financing efforts; and anticipated spending for R&D in 2024. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this presentation in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. ​

###

Moderna Contacts

Media:
Chris Ridley
Head, Global Media Relations
+1 617-800-3651
Chris.Ridley@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

View the original press release on accesswire.com

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26Mar

These Inhalers No Longer Cost More Than $35 Per Month

Posted by: admin Categories: PULMONARY DISEASES
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Key Takeaways

  • Three major pharmaceutical companies have announced price caps for their inhalers.
  • The inhalers treat patients with asthma and COPD.
  • Changes were made in response to pressure from lawmakers.

Amidst untenable drug prices, there's finally some good news: Several pharmaceutical companies are capping the out-of-pocket price of select inhalers at $35.

GlaxoSmithKline (GSK) is the latest company to announce a price cap this month, following the lead of AstraZeneca and Boehringer Ingelheim, who revealed their inhaler price ceilings in March.

The news “builds on GSK’s strong track record of increasing access and improving the affordability of its medicines, including an ongoing commitment to responsible pricing,” the company said in a statement.

AstraZeneca shared a similar sentiment, stating that the company “remains dedicated to transforming patient outcomes, while ensuring access and affordability of our innovative medicines.” Boehringer Ingelheim, which was the first to announce an inhaler price cap, said in a statement that its program “builds on the company’s long-standing commitment to supporting patients.”

But this shared commitment to improved patient experiences isn’t a coincidence. The price caps come after lawmakers criticized the companies, along with Teva Pharmaceuticals, for having high prices. (Teva Pharmaceuticals has not announced plans for an inhaler price cap.) In a letter sent to the companies, the lawmakers noted that prices for these monthly inhalers are much higher in the U.S. than abroad.

“There is no rational reason, other than greed, as to why GlaxoSmithKline charges $319 for Advair HFA in the United States, but just $26 for the same inhaler in the United Kingdom,” Sen. Bernie Sanders, chairman of the Senate Committee on Health, Education, Labor, and Pensions, said in a statement. “It is unacceptable that Teva is charging Americans with asthma $286 for its QVAR RediHaler that costs just $9 in Germany. It is beyond absurd that Boehringer Ingelheim charges $489 for Combivent Respimat in the United States, but just $7 in France.”

Purvi Parikh, MD, an allergist with Allergy & Asthma Network, told Verywell Health that this is "great news" for people with asthma and chronic obstructive pulmonary disease (COPD).

“Many patients, including my own, cannot afford their inhalers despite having health insurance due to exorbitant costs,” Parikh said. “Even to get these meds covered, there are hoops that doctors must jump through to get prior authorizations and approvals, which delays medical treatment for our patients. This will help people get on their medications sooner.”

The price cut eligibility varies between brands. Here’s a breakdown.

GSK

GSK announced its $35 out-of-pocket price cap on March 20, though it’s not the first example of patient assistance offered by the company.

“In the U.S., we already provide significant rebates and discounts for our products, as well as patient assistance programs, to help bring down costs,” Maya Martinez-Davis, president of U.S. Commercial, GSK, said in a statement.

Which Inhalers Does This Apply To?

The new price cap impacts all of GSK’s asthma and COPD medicines. Specific inhalers impacted include:

  • Advair Diskus (fluticasone propionate and salmeterol inhalation powder)
  • Advair HFA (fluticasone propionate and salmeterol inhalation aerosol)
  • Anoro Ellipta (umeclidinium and vilanterol inhalation powder)
  • Arnuity Ellipta (fluticasone furoate inhalation powder)
  • Breo Ellipta (fluticasone furoate and vilanterol inhalation powder)
  • Incruse Ellipta (umeclidinium inhalation powder)
  • Serevent Diskus (salmeterol xinafoate inhalation powder)
  • Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder)
  • Ventolin HFA (albuterol sulfate inhalation aerosol)

GSK said that it will share more details closer to when the price caps roll out.

Who Is Eligible?

Most people are eligible for the price ceiling.

“The program covers those with commercial insurance and those who are uninsured,” Lyndsay Meyer, director of U.S. Corporate Media Relations at GSK, told Verywell.

However, those who are in federal government insurance plans may not receive this benefit.

“Government restrictions exclude people enrolled in federal government insurance programs from co-pay support,” Meyer said.

 When Do These Price Caps Take Effect?

GSK said that the price cap will go into effect no later than January 1, 2025.

AstraZeneca

AstraZeneca announced on March 18 that it would roll out a savings program.

“We remain dedicated to addressing the need for affordability of our medicines, but the system is complex and we cannot do it alone,” Pascal Soriot, Chief Executive Officer of AstraZeneca, said in a statement. “It is critical that Congress bring together key stakeholders to help reform the healthcare system so patients can afford the medicines they need, not just today, but for the future.”

Which Inhalers Does This Apply To?

The price cap applies to inhalers for asthma and COPD. Those include:

  • Airsupra (albuterol and budesonide) 
  • Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 
  • Breztri Aerosphere (budesonide, glycopyrrolate, and formoterol fumarate) Inhalation Aerosol 
  • Symbicort  (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol 

AstraZeneca also said that it “substantially reduced” the price of Symbicort on January 1.

Who Is Eligible?

The price cap will apply to people who have health insurance, as well as those who are uninsured and underinsured.

When Do These Price Caps Take Effect?

AstraZeneca’s price caps will go into effect starting June 1, 2024.

Boehringer Ingelheim

Boehringer Ingelheim was the first company to announce a price cap, revealing the news on March 7.

Jean-Michel Boers, president and CEO of Boehringer Ingelheim USA Corporation, said in a statement that the company wants “to do our part to help patients living with COPD or asthma who struggle to pay for their medications” and will “continue to advocate for substantive policy reforms to improve the healthcare system.”

Which Inhalers Does This Apply To?

This applies to a range of inhalers the company makes to treat asthma and COPD, including:

  • Atrovent HFA (ipratropium bromide HFA) Inhalation Aerosol
  • Combivent Respimat (ipratropium bromide and albuterol) Inhalation Spray
  • Spiriva HandiHaler (tiotropium bromide inhalation powder)
  • Spiriva Respimat 1.25 mcg (tiotropium bromide) Inhalation Spray
  • Spiriva Respimat 2.5 mcg (tiotropium bromide) Inhalation Spray
  • Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray
  • Striverdi Respimat (olodaterol) Inhalation Spray

 Who Is Eligible?

Boehringer Ingelheim said the program will help people who are insured, as well as those who are uninsured and underinsured.

When Do These Price Caps Take Effect?

The price caps start on June 1, 2024, Boehringer Ingelheim said.

What This Means For You

If you use an inhaler for asthma or COPD, it may soon become more affordable. If your go-to inhaler isn’t impacted by the out-of-pocket price cap, talk to your healthcare provider. They may be able to recommend an alternative that is under the price cap. And yes, it’s possible that you may end up paying less than $35 for an inhaler from one of these companies, depending on your insurance.

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26Mar

High-Flow Nasal Cannula Therapy in ARDS Patients

Posted by: admin Categories: PHYSICAL REHABILITATION
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Introduction

The high-flow nasal cannula (HFNC) has become an essential non-invasive oxygen therapy device. Recently, it has been used widely in clinical settings as a non-invasive respiratory support method to improve oxygenation in adult patients.1 HFNC has several advantages over conventional low-flow devices (eg, nasal cannula or simple face masks): enhanced patient comfort, increased humidification, improved secretion clearance and reduced effort in breathing.2,3 The HFNC system is a unique device that is simple and easy to use, needing only an active heated humidifier, flow generator, single circuit, and soft nasal cannula.4 This device was developed to maintain high oxygen flow and improve the efficiency of ventilation by delivering warmed and humidified oxygen with a flow rate as high as 60 L/minute and a fraction of inspired oxygen (FiO2) of 0.21 to 1.0. An increased flow rate can help reduce inspiratory effort and improve dynamic lung compliance, which can lead to improving oxygenation and ventilation.1,5,6 During the COVID-19 pandemic, several studies showed that the use of HFNC as an alternative oxygen device for respiratory failure patients can provide higher oxygen concentrations than can be achieved with conventional devices, reduce the need for endotracheal intubation, and decrease the length of stay in intensive care units (ICUs).7–9 In addition, HFNC has a valuable effect in reducing anatomical dead space, which provides low positive end-expiratory pressure (PEEP) and can be more tolerable for patients with chronic obstructive pulmonary disease (COPD).10 Moreover, the immediate use of HFNC for postoperative respiratory failure patients was associated with lower risks of reintubation and respiratory failure.11

Even though the use of HFNC is prevalent in clinical settings, RTs still lack evidence-based guidelines for implementing HFNC.12 Moreover, HFNC is frequently utilized by RTs but controversy remains on the initiation, management and weaning of HFNC due to scant evidence.12–14 A cross-sectional study of French ICU physicians found that there was a great deal of variability in the current use of HFNC, including the criteria for initiation and weaning.15 Furthermore, a global survey of intensive care unit (ICU) healthcare providers reported that there was considerable variation in the daily application of HFNC with regard to initial settings and management criteria for HFNC parameters.16 HFNC failure may result from these notable differences in clinical practice, which is probably due to lack of educational training and standardized protocols.17

Despite the wide use of HFNC and the studies exploring the benefits of using HFNC with ARDS patients, research into assessing the knowledge, practice, and barriers to using HFNC among respiratory therapists in Saudi Arabia is lacking. Therefore, this study aimed to assess the current practice of HFNC in multiple centers in Saudi Arabia and identify the barriers to using HFNC among respiratory therapists.

Methods

Study Design

In this cross-sectional study, a survey was distributed through an electronic platform SurveyMonkey between December 19, 2022, and July 15, 2023.

Instrument

Experts in the use of HFNC (namely ICU physicians, respiratory therapists, and ICU nurses) formulated this questionnaire, which was adapted and modified from previous studies.8,15,16,18 Next, face and content validity were assessed by an expert panel and the survey was then pilot-tested. After receiving feedback from the experts, adjustments were made, and the survey was distributed. The survey consisted of six main parts:

  • The first part asked the participants about their demographic information (eg, gender, number of years working in critical care areas, and geographical location).
  • The second part focused on assessing the study participants’ knowledge of indications for the use of HFNC. This part consists of 13 statements with a five-point Likert scale ranging from 1 to 5 (1 = strongly agree; 5 = strongly disagree).
  • The third part consisted of four statements with a five-point Likert scale ranging from 1 to 5 (1 = strongly agree; 5 = strongly disagree). This section assessed whether respiratory therapists agree that 1) the HFNC device is tolerable for patients, 2) HFNC is used to help patients eat and speak, 3) HFNC improves dyspnea, and 4) HFNC is used to avoid the need for intubation and invasive mechanical ventilation.
  • The fourth part assessed the study participants’ ability to determine the timing for switching to HFNC, the most appropriate initial settings for HFNC, the management of patients on HFNC, and the criteria required for weaning.
  • The fifth part consisted of four statements to evaluate whether the study participants were aware of the criteria for HFNC failure and the time to intubate and use invasive mechanical ventilation.
  • The last part consisted of one question about barriers to HFNC use.

Data Collection and Sampling

A convenience sampling strategy was used to recruit the study participants, and the main target population for this study were respiratory therapists who work in Saudi Arabian hospitals and hold a bachelor degree. To reach a larger population of respiratory therapists, we distributed the survey through Saudi scientific non-profit organizations (eg, the Saudi Society for Respiratory Care) along with social media platforms (X and WhatsApp). In addition, each data collector visited and circulated the survey to respiratory therapists working at their nearby tertiary hospitals.

Data Analysis

The collected data were managed and analyzed using the Statistical Package for the Social Sciences (SPSS) version 27. Data were presented as means and standard deviation or frequency and percentages, as appropriate. A Chi-square test was used to compare RT staff who have existing HFNC protocols and those who do not. A p-value of <0.05 was considered statistically significant.

Ethical Approval

Before the commencement of the study, ethical approval was obtained from the Bioethical Committee at Batterjee Medical College (Reference Number RES-2022-0077).

Results

Participant Characteristics

In this study, 1001 RT practitioners completed the online survey. Over half of the participants were female (573, or 57.2%). The majority of our sample was staff specialists (824, or 82.3%), while directors of RT departments accounted for 29 (2.9%). High numbers of representatives were from the country’s Western and Central Regions (52.8% and 26.4%, respectively). More than half (56.1%) of the participants had one to five years of clinical experience. In addition, we documented the areas where the respiratory therapists were assigned, such as critical care (78.6%), non-critical care (65.5%), and ER (57.9%). Two-thirds of the respiratory therapists (659, or 65.8%) had received training on HFNC and 785 (78.4%) had used HFNC in clinical settings. (See Table 1).

Table 1 Demographic Data and Characteristics of Study Respondents (n = 1001)

Indications of Using High-Flow Nasal Cannula from the Perspective of RT Staff

We asked the participants if they agreed about the relevant indications or conditions that require HFNC. The top responses were COVID-19 (78%), post-extubation (65%), and do-not-intubate patients (64%). The lowest responses were pre-oxygenated patients before intubation (38%), obesity-induced hypoventilation syndrome (34%), and sleep apnea syndrome (33%). (See Table 1 and Figure 1).

Figure 1 Indications for using HFNC from the perspective of RT staff (n=1001).

Advantages of Using High-Flow Nasal Cannula

Four advantages of HFNC (ie, has high tolerability, helps maintain conversation and eating abilities, improves shortness of breath (SOB), and avoids intubation) were reported from the perspective of respiratory therapists. Participants strongly agreed that the advantages of HFNC were helping to maintain conversation and eating abilities (32.95%) and improving SBO (34.1%) (See Table 2 and Figure 2).

Table 2 Advantages of Using HFNC from the Perspective of RT Staff

Figure 2 Advantages of using HFNC from the prospective of RT staff (n=1001).

Initial Settings, Weaning and Disconnect of High-Flow Nasal Cannula

Surprisingly, 568 (57%) of RT staff do not follow a protocol for initiation, weaning and disconnection of HFNC with ARDS patients.

When starting HFNC, 40.2% of the participants started with FiO2 of 61% to 80%. Additionally, a high percentage of RT staff (40.6%) started with a flow rate between 30 L/minute and 40 L/minute and a temperature of 37°C (57.7%). When weaning ARDS patients from HFNC, 482 (48.1%) recommended first reducing gas flow by 5–10 L/minute every two to four hours, followed by 362 (36.2%) who recommended first reducing FiO2 by 5–10% every two to four hours. Moreover, 549 (54.8%) believed that ARDS patients could be disconnected from HFNC if they achieved a flow rate < 20 L/minute and FiO2 <35%. (See Table 3).

Table 3 Clinical Practice of HFNC

In addition, we compared the responses between participants who followed a standardized protocol versus those who did not follow a protocol to initiate, wean and disconnect HFNC. (See Table 3).

Of the 402 RT staff who would start with FiO2 between 61% and 80%, 289 (28.87%) reported not following a standardized protocol. Additionally, half of the RT staff (214, or 21.42%) who would start with a flow rate between 30 and 40 L/minute do not have a standardized protocol to follow. Among all participants, we observed a statistically significant difference between respiratory therapists who follow a protocol versus those who do not (p-value <0.001). For those who recommended first reducing gas flow by 5–10 L/minute every two to four hours when weaning ARDS patients, 356 (35.51%) did not follow a standardized protocol. Among all participants, we observed statistically significant differences between respiratory therapists who follow a protocol and those who do not follow a protocol (p-value <0.001). (See Table 3).

Criteria to Stop High-Flow Nasal Cannula and Intubate Acute Respiratory Distress Syndrome Patients

Regarding the criteria to stop providing HFNC and initiate intubation, 39.5% of the participants would stop providing HFNC if the patient paused or stopped breathing. Indeed, 34.7% of the participants would stop providing HFNC in cases of refractory hypoxemia (SpO2 < 90% with FiO2 100% and flow rate of 60 L/minute), 35% in cases of severe respiratory acidosis (pH is unacceptably low (<7.25) and the PaCO2 is elevated), and 39.3% in cases of reduced level of consciousness (GCS score ≤8). (See Table 4).

Table 4 Criteria to Stop HFNC and Intubate ARDS Patients

Challenges in Using High-Flow Nasal Cannula

Regarding the challenges that impede the use of HFNC, participants ranked lack of knowledge, lack of devices, and the absence of protocol as the highest challenges (57.3%, 49.6, and 49%, respectively) while lack of evidence and diversity of HFNC devices were the lowest challenges 34.5% and 17.2%, respectively. (See Figure 3).

Figure 3 Challenges toward using HFNC from the perspective of RT staff (n=1001).

Discussion

To the best of our knowledge, this is the first national study to shed light on the knowledge, attitudes, and current practice of HFNC in ARDS patients among respiratory therapists in Saudi Arabia and the barriers to its use in clinical settings. The study findings revealed nuanced applications marked by significant endorsement in certain clinical scenarios and a lack of protocol adherence, underscoring the need for uniform, evidence-based guidelines and enhanced training for respiratory therapists.

A significant finding in our study is the prominent endorsement of HFNC use in COVID-19 patients, post-extubation cases, and do-not-intubate patients. These results corroborate existing literature that underscores HFNC’s role in enhancing oxygenation and reducing the effort of breathing in acute hypoxemic respiratory failure.2,3 Similarly, a cross-sectional study disclosed that respiratory physicians in Japan regarded COVID-19 as a primary indicator for HFNC application given its propensity to reduce the frequency of sustained sedation, physical restraint, and length of stay in the ICU compared to patients undergoing non-invasive ventilation (NIV).8 Nevertheless, the lower agreement on HFNC’s application in pre-oxygenation, obesity-induced hypoventilation, and sleep apnea conditions indicates potential knowledge gaps or diverse clinical experiences that warrant further investigation.

HFNC therapy has garnered widespread clinical validation for its efficacy in the management of patients with ARDS. Its capacity to deliver a precise and adjustable flow of warmed, humidified oxygen optimizes patient comfort and oxygenation status and decreases respiratory distress symptoms and the risk of endotracheal intubation.19,20 Within the scope of the present study, a substantial level of consensus was observed among participants, indicating that HFNC application is associated with a notable amelioration of SOB while concurrently preserving speech and eating capabilities. In line with these findings, previous literature has demonstrated the superiority of HFNC over alternative non-invasive respiratory modalities, underscored by its high patient tolerance and preservation of patients’ daily activities, emphasizing HFNC’s pivotal role in enhancing patient-centered outcomes.8

In the current study, significant discrepancies were observed in the setting of initial parameters, weaning strategies, and disconnection criteria pertaining to HFNC. Specifically, a majority of respiratory therapists reported an initial application of FiO2 within the range of 60% to 80%, a flow rate of 30–40 L/minute, and a temperature of 37°C. Notably, these findings are inconsistent with established HFNC protocols, which advocate initiating FiO2 at 1.00, a flow rate of 60 L/minute, and a temperature of 37°C.21,22 Furthermore, a substantial proportion of respiratory therapists expressed a preference for initially weaning the flow rate by 5–10 L/minute every two to four hours, deviating from the guidelines stipulated by the Canadian Society of Respiratory Therapists, which prioritize reducing FiO2 to less than 40% before commencing a gradual decrement in flow rate by increments of five.21 Analogously, heterogeneous practices were observed among French ICU physicians during the weaning process of HFNC settings.15 Despite these variations, a significant consensus emerged among over half of the respiratory therapists regarding the disconnection of HFNC, advocating for disconnection when the FiO2 is below 35% and the flow rate falls below 20 L/minute, aligning with published guidelines.1,21 A noteworthy revelation is the lack of adherence to standardized protocols for initiating, weaning, and disconnecting HFNC for ARDS patients. This inconsistency in clinical practices underscores the urgent need for the development and dissemination of evidence-based guidelines to enhance the quality and consistency of patient care.

Regarding the criteria dictating the transition from HFNC therapy to invasive mechanical ventilation in patients with ARDS, our study revealed a moderate consensus. This alignment was substantiated through the initiation of endotracheal intubation in cases of spontaneous breathing cessation, refractory hypoxemia, severe respiratory acidosis, or diminished consciousness. Concomitantly, a subsequent study yielded analogous outcomes, thereby affirming our findings. Notably, it illuminated the exacerbation of respiratory distress and the presence of bronchial congestion as substantive contributors to the ineffectiveness of HFNC therapy, consequently augmenting the imperative for invasive ventilation.15 Additionally, a retrospective analysis furnished empirical evidence identifying hypoxemic and hypercapnic respiratory failure as crucial indicators denoting the failure of HFNC therapy, particularly in scenarios wherein patients cannot sustain SpO2 above 90% despite receiving maximal FiO2. This insufficiency is accentuated by concomitant findings of arterial pH below 7.3 and respiratory rates exceeding 35 breaths per minute.23 The diverse criteria employed by respiratory therapists to discontinue HFNC and commence intubation emphasize the need for standardization in this aspect. Precisely articulated and evidence-based criteria are instrumental in optimizing patient outcomes and mitigating the potential risks associated with delayed intubation.

Several barriers impede the widespread adoption of HFNC therapy in clinical settings. In the present study, RT staff identified a lack of knowledge, the unavailability of devices, and the absence of protocols as the foremost challenges hindering the optimal use of HFNC. In accordance with these results, existing literature has shown that a lack of skill and familiarity hampers the implementation of HFNC in the ICU.24,25 Likewise, a pertinent study revealed that the absence of established objective criteria for initiating and managing HFNC settings significantly restricts its application, potentially leading to ineffective healthcare practices.26 These findings underscore the necessity for targeted interventions to enhance the capabilities of respiratory therapists, ensure the availability of essential equipment, and establish evidence-based protocols and the importance of concerted efforts to fortify strengths and mitigate the challenges associated with HFNC application in clinical settings.

Strengths and Limitations

One of the notable strengths of this study is the breadth of the participant sample, offering a robust spectrum of insights and experiences from a diverse group of respiratory therapists. The comprehensive survey methodology enabled the capture of nuanced, multifaceted data, allowing for a granular analysis of HFNC practices and challenges. Additionally, the alignment of the study’s findings with existing literature accentuates its validity and contribution to the ongoing discourse on the clinical applications of HFNC. Nevertheless, the study has limitations. We did not assess the current practice and barriers of using HFNC from the prospective of physicians whose practices maybe different from RTs. The reliance on self-reported data introduces the potential for response biases, wherein participants might either consciously or unconsciously misreport their practices. The cross-sectional nature of the study design precludes causal inferences and the assessment of HFNC practice evolution over time. Moreover, the geographical and institutional diversity of participants, while a strength, also raises questions about the generalizability of the findings across different contexts and healthcare systems.

Conclusion

Respiratory therapists in Saudi Arabia demonstrated a profound understanding of the clinical advantages associated with the utilization of HFNC for adult patients with ARDS. However, significant discrepancies were observed concerning the setting of initial parameters, the formulation of weaning strategies, and the determination of disconnection criteria related to HFNC. These variations primarily stemmed from inadequate adherence to established protocols and limitations in available resources. Such observations underscore the imperative for the development and implementation of standardized, evidence-based guidelines, alongside comprehensive training initiatives aimed at enhancing respiratory therapists’ compliance with HFNC protocols.

Data Sharing Statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Ethical Approval

This study was approved from Bioethical Committee at Batterjee Medical College (Reference Number RES-2022-0077) and conducted in accordance with the Declaration of Helsinki. Informed consent was obtained from all RTs participated in the study.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Funding

There is no financial supporting body for this study.

Disclosure

The authors report no conflicts of interest in this work.

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26Mar

The Right Inhaled Medication at the Right Price

Posted by: admin Categories: PULMONARY DISEASES
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Leah J. Witt, MD: Hello. I'm Dr Leah Witt. Welcome to season one of Medscape InDiscussion, chronic obstructive pulmonary disease (COPD) podcast series. Today we're talking medications, especially inhalers and COPD; everything from correct use, cost, and tips for prescribing. I am beyond excited to welcome my friend and today's expert guest, Dr Amber Lenae Martirosov. Dr Martirosov is an ambulatory care clinical pharmacist at Henry Ford Health and an associate clinical professor at Wayne State University. She describes herself as a huge advocate for patients. She practices in an outpatient clinic, where she improves patient outcomes by focusing on getting patients the right inhaled medication at the right price. Welcome to the Medscape InDiscussion podcast, Amber.

Amber Lenae Martirosov, PharmD: Thanks for having me, Leah. It's great to be here.

Witt: We've talked a lot about this topic, and we're going to get into it. Before we do, I want to kick off the episode by getting to know you. What is on your mind outside of medicine?

Martirosov: I've been doing this new thing that I call revenge reading, where I stay up too late reading books because I want to be able to read books. I'm currently reading The Wager, which is a really fascinating book about potential mutiny aboard a ship. It's a really good book. I would recommend reading it.

Witt: I'm revenge listening. I haven't gotten to reading because I fall asleep too fast, but I love podcasts. I started listening to Emily Oster's ParentData podcast. She's an economist who dives into the data about pregnancy and parenting. She has a podcast, and I was just listening to the episode where she interviewed Eve Rodsky, who wrote Fair Play. I highly, highly recommend. She takes such a scientific approach that I think anybody who's in medicine could really appreciate that approach.

Let's get into our case. I'm going to keep our patient the same as in the last episode, and we're going to talk about Mr Rivera. Today, we're talking about medications, especially inhalers. He's a 78-year-old man. We diagnosed him with COPD last episode. He was hospitalized with a COPD exacerbation.

You're seeing him for the first time in your pulmonary clinic to talk about medications. He was discharged from the hospital with a tiotropium soft-mist inhaler (SMI) and albuterol. There was a meds-to-bed initiative. He got the medications, but he doesn't know how to use them. I want to start by asking you, how do you approach that first post hospital follow-up visit?

Martirosov: This is an important question to consider, especially from a provider perspective. One of the things that we see commonly with inhalers is that patients will get inhalers, and either the provider doesn't educate the patient or believes that the patient will be educated when they get to the pharmacy.

This is a missed opportunity for education. We're often seeing these patients say, "I don't know how to use these devices." It's important to understand with this patient specifically that tiotropium SMIs requires the patient to put it together.

It's not packaged in a box that's ready to go. The patient must do some work to assemble it. When I first see these patients, the first question that's always important to ask is, "What inhalers have you used in the past? Can you tell me about how you use them?" If they have not used inhalers, then the next question I ask is, "What do you think you should be doing with this inhaler?" We can start with the knowledge they have and build on that. We then systematically go through the different steps of appropriate use of the different types of inhalers. We go into those nuanced details. When should they be holding their breath? When should they be blowing out their nose? We talk about things like that.

Witt: We have a secret love of both inhaler technique and Medicare Part D. We'll get into that in a second. I want to talk about the new Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, the holy grail of COPD management, which now recommends for group E, that's the high exacerbation group that he's in because he was hospitalized for an exacerbation, to start a long-acting beta-agonist (LABA)–long-acting muscarinic antagonist (LAMA). This is the same as group B, which is defined as high symptoms and a moderate number of exacerbations. Why do you think that is? Why do the GOLD guidelines suggest going right for the LABA-LAMA initially?

Martirosov: This taps into the pharmacist brain because we're going to talk about pharmacology. When you think about the way that LABAs work and the way that LAMAs work. They are both bronchodilators by nature, but they are targeting different receptors. The LAMA has an added benefit of targeting muscarinic receptors, which then would cause a little bit of anticholinergic effects.

When we combine a LABA with a LAMA, we get this phenomenon known as dual bronchodilation with the added bonus of a little bit of that antimuscarinic effect. This is fantastic for your patients with COPD who we know are going to have some limitations in their breathing and need that bronchodilator to open those airways.

We know that in COPD, these patients are oftentimes going to have a lot of mucus. Now, not only are we opening up those airways, but we are getting an antimuscarinic in there that's going to help to dry up some of that mucus so that the patient either is able to clear it themselves, or the body will naturally take care of the rest.

Witt: Our patient left the hospital with just a LAMA. Would you switch him right away or would you wait and see how he does?

Martirosov: I would ask a couple of questions, but my short answer is yes. We need to switch him because that's what's actually going to benefit this patient. Given the fact that he's already had an exacerbation that led to a hospitalization, we are trying to do everything we can to prevent future exacerbations because that means future worsening of overall lung function.

The short answer is that we want to switch him. But before we do, I want to make sure that he is able to even afford the tiotropium he got on the first round. Then, I would like to assess his ability to use the inhalers before I decide which of the combination therapies I want to switch him to.

That's so important to think about when switching therapies and devices. If your patient couldn't use the first device, you're setting them up for failure because they're not going to be able to use the new device that you give them, even though you're giving them the correct drug therapy.

Witt: What are some of the device delivery options and how would you assess what to give him?

Martirosov: We always have to think about three different types of devices, and then we throw nebulizers in on the back end. Our historic albuterols have always been what we call a metered-dose inhaler (MDI). Then we have dry-powdered inhalers (DPIs). Many people are going to think of the Advair or (the fluticasone propionate–salmeterol Diskus).

Then we have the newer class, which is actually what this patient was prescribed; SMI. Now, I want to make a quick note. I said three, but within the MDI category, the QVAR RediHaler [beclomethasone dipropionate HFA], and it's the only one of its type, is actually what we call a breath-actuated inhaler.

It operates just like a MDI, but instead of the patient having to depress a canister, the canister will naturally depress as the patient inhales. It is a breath-actuating canister depression that it administers it. It is the only device like that. It technically falls under a metered-dose, but just want to make sure our audience is aware of those differences.

One of the things that's really important when we think about these different devices is the breath technique. This morning, I had a conversation with one of our respiratory therapists (RTs), who's been an RT for 40 years. She said, "Wait, we don't use MDIs quick and fast?" And I said, "Actually that's the worst way to use them." If you think about a MDI or a breath-actuated inhaler, there is a forceful spray behind that. If the patient matches that with a forceful and quick inhalation, the only place that medication can go is to the back of the throat. What we want our patients to do is create a very soft breath. When they start to inhale, we don't even want it to be audible. It should be just like a normal respiratory effort, slow and steady. They should press the canister for about 1-2 seconds after they've started to inhale and then continue that inhalation process for as long as possible. That's different from a DPI. With a DPI, we have this powder that we have to aerosolize. With that device, what we actually want our patients to do is take a very deep and steady breath. Their breath should be audible, but it needs to be steady enough that the patient can inhale for about 4-5 seconds to ensure that that medication will deposit within the lungs.

With those SMIs, the technique should be identical to that of what we would use for the MDI. That very slow, steady, not audible breath for as long as possible.

Witt: It's hard for patients to understand all the technique differences. It's not something that I learned in training. Learning yourself and training yourself is really the first step. I know that in pharmacy school, you get a lot more education about that. I'm sure you've had a lot of experience teaching other doctors about how to use inhalers. What have you seen? We're terrible, right?

Martirosov: I work in a pulmonary clinic, and every year, I test our fellows. In 10 years of practice, I can count on one, maybe one and a half, hands how many of our fellows have gotten it correct with their inhaler technique. That's important to talk about because these are pulmonologists, they're trained to be able to educate patients. There are a lot of different devices, and there's a lot of things that physicians have to master. Asking them to then get inhaler technique right and being able to classify these devices the correct way so that they can educate correctly, that's intimidating. It also may not be something physicians want to spend their time on, when they have other diagnostic things to consider to ensure that patients get the best care.

There are some great tools, though, that you could easily use. There are some great apps that you can download on your phone that make it easier for you as a physician to just pull out your phone and say, "Hey, let's look at this together to make sure that we're doing this correctly."

There are also good resources through the Asthma & Allergy Network, which give you a nice picture of all the different device types and explains whether it's a MDI, breath-actuated inhaler, DPI, and things like that. There is also a new one through the American Lung Association.

There are some tools that you can use to assess whether or not your patient can use their inhalers correctly. Currently, there are two that have been studied. The first one I'll talk about is the Vitalograph Aerosol Inhalation Monitor. What's nice about this is you can use it to train your patients on the correct breath technique. You can also use it to assess them.

If they're not able to correct that technique after multiple education attempts, then that tells you that they need to switch to a different device. The second device that we can use is only going to help you assess inspiratory effort, and whether or not your patient is going to be able to generate enough flow to aerosolize the product appropriately. That device is called the In-Check DIAL.

Witt: The app that I love is the COPD Foundation app. They have a list of inhalers that you could choose by category, and then in the app, but also on YouTube, they have videos that you can share. This highlights how important the interprofessional team is because we all educate ourselves as much as we can. For example, we rely on you as a pharmacist in the clinic, or our advanced practice providers who are skilled at teaching patients about device use. It's so important. Do you have any idea of what you would recommend for our patient, Mr. Rivera? In the second part of the case, I chose one. If he had arthritis, for example, or cognitive impairment, how would you think about that?

Martirosov: I'm a big fan of the SMIs because it is such a nice delivery device for patients that might have advanced COPD. They may lack inspiratory effort. That soft mist replicates a nebulizer machine so we can ensure that the patients are getting more deposition into the lungs.

It comes back to whether the patient can put it together. If this patient has arthritic hands and isn't able to open the device to put the actual canister in and then twist it to be able to administer the dose, that's a problem. In that case, we would probably want to switch them to an alternative agent.

I find that some of my big, barreled-chest patients are great at that deep, steady breath. But then, when I ask them to slow it down, they say, "I don't know what you're talking about. I don't know how to do that." In that patient, where I can't get them to do that very slow, not audible, steady breath, I'm probably going to want to switch to a DPI. I know that DPIs, in this patient, is likely going to get better absorption down into the lungs vs the back of the throat. We would get the back of the throat deposition if this patient was using an SMI or that MDI, because they're using that very deep, breathy, inhalation technique.

Witt: Let's continue the case. Perhaps this hospitalization happened at the end of the year. Mr Rivera sends you a MyChart message in January. This is the beginning of the year on his next refill, you switched him to a LABA-LAMA, a low tiotropium-olodaterol SMI. He says his out-of-pocket cost is $450. He chose a Medicare Part D plan during open enrollment years ago before he had any medical problems, and he hasn't changed it since. He chose it based on the lowest monthly premium, but it has a high deductible. He asks whether you have any advice for him. I'm the medical director of our clinic. I see this every January, and I get a lot of questions like I don't understand why are the costs so high? Where are we getting so many medication rejections messages from pharmacists? Can you explain what's happening?

Martirosov: This is Medicare in a nutshell. We have three parts of Medicare that really cause problems for us as providers. The first is January, when the Medicare cycle restarts. If a patient has a deductible, that deductible will be due in January, which means when they go to pick up their high-cost drugs, typically brand-name drugs, they will be responsible for paying that deductible before they are able to get whatever their insurance pricing is.

I would bet money that this patient is in that initial coverage phase. Because of that, he is now responsible for this high deductible before his insurance will cover the cost of that drug for him. Then, he's going to get into a stage where he's going to be great, maybe he'll be able to afford it, maybe he won't.

I suspect that he's probably going to struggle if he picked an insurance plan based on the lowest premium, because oftentimes the lowest premium means the highest out of pocket costs for our patients. He'll be in what we consider like the coverage phase where maybe he only has to pay $45 for that brand name inhaler, or maybe he has what we would call a co-insurance where he's responsible for 20% or 30% of the average wholesale price.

What happens, though, in a lot of these patients, especially patients who pick their insurance plans based on the lowest premium, is that toward the later part of the year, usually August, September, if they are on a lot of high-cost drugs, they're going to enter what we call the coverage gap or that donut hole. That's a term many of you are probably familiar with. Now, the costs go up again, and that's because the patient has reached their maximums that the insurance have set, in terms of drug costs or other costs. The patient is now responsible for a larger share until they can get themselves out of that donut hole and into what we would then call catastrophic coverage. Leah, we have talked about Medicare. You and I are both very passionate about how we all need to understand this better. We need to be able to better educate our patients on this so that they can make better informed decisions, but it's such a hard thing, especially in the pulmonary world, because we have so few generics that we can rely on. More so than a lot of other, disease states and organ systems, we see a lot of issues with the Medicare plan coverages because we don't have generics to fall back on, so that we can provide our patients with different options.

Witt: So much changes year to year. This year, in 2024, there are good changes. The Inflation Reduction Act that was passed in 2022 is starting to lower some costs. It's eliminating the cost sharing for drugs in the catastrophic phase of coverage. Functionally, the cap is going to be around $3300 dollars, and then 2025, the cap will be $2000 dollars. That will help. But just like you said, planning for January is so important. Then, there are formulary changes, where the inhaler that a patient was on the previous year may not be the preferred inhaler. That's so hard and so disruptive.

Martirosov: To add to your point this year, that disruption was even worse. In late December, we found out that Flovent is no longer going to be available, but then all these formularies for January 2024 said that Flovent is their preferred inhaled corticosteroid. But wait, it's not available.

What do we do? At least in my clinic, it required a lot of prior authorizations because we had to figure out what was going to be covered or wait for them to come out with new formularies. I agree, the formularies are difficult. Understanding Medicare Part D as a collective whole is difficult.

Some of the Inflation Reduction Act is going to make a big difference, and overall, when we think about the Affordable Care Act, one of the goals was that it was going to shrink down that donut hole, that coverage gap, and it slowly but surely has. We've seen legislation about insulin and things like that, but we still have a long way to go before we make a difference in our pulmonary patients.

Witt: Do you have tips? This medication could easily be on his formulary, and his out-of-pocket cost is just high because he hasn't reached his deductible yet. Is there any way to know for sure, when you send it to a pharmacy, if it's going to be on the formulary? Are you counseling people in advance that it might be expensive? How do you navigate that?

Martirosov: It's a hard thing to navigate. One of the things you can do is trying to be aware of the resources are available to you. There are a couple of different websites like CoverMyMeds. These prescription websites will give you an idea of what the formularies are. The problem is that they are never 100% accurate because formularies change.

One Blue Cross Blue Shield insurance card, depending on which patient it's going to, may have five different formularies. The first thing is educating your patients. You brought up a good point, talking to the patients and saying, "Hey, these medications can be expensive. Don't hesitate to call me or call the clinic if it is expensive so that we can then intervene on your behalf." That's number one. Number two is being willing to try to see if there are drug assistance programs through the manufacturer. Something like tiotropium-olodaterol is still brand-name only. As such, there is federal legislation that even for your Medicare patients, while they're in the coverage gap for Medicare Part D, you could potentially get that patient free drug from the manufacturer for the rest of the year, which is a big win.

It's something that we have done in my clinic successfully for a very long time. I'm not always the biggest fan of things like GoodRX or shopping around, but if your hands are tied, you have to do the best that you can with potentially using GoodRX or, you know, some equivalent to that website. You might be able to say, Hey, your insurance is going to be, $400.

But if you pay cash price at this store with this coupon, it's only $120. Sometimes that is enough to make a difference. The last thing that I will mention, which I don't blanket say that we should do for our patients, is there's always nebulized solutions.

Here's the tricky thing with nebulized solutions. You have to determine whether or not the patient is covered by Medicare Part D vs Medicare Part B. With Medicare Part B, the patient often has a 20% coinsurance, which is oftentimes much cheaper than that deductible or whatever they're required to pay in the donut hole.

However, that doesn't always apply for our LAMAs or LABAs because they're brand-name only. So sometimes, if there is a patient with Medicare Part B vs D, and at your very worst, you have to get your patient something, there is always the alternative of putting them on short-acting beta-agonist and short-acting antimuscarinic, like ipratropium, but then scheduling it so that it's used around the clock like it's a long-acting agent. It's not perfect, but when you're desperate, you have your work around. It's an option. It's not the best option, and I would reserve it only in your patients where you're desperate to do something,

Witt: Thank you so much for reviewing this. There's always so much to learn. The last thing I always encourage people to do is review their Part D plan every fall during open enrollment. There's a really good website called Medicare Plan Compare. You can put in your medications and see what the best plan is for you. There are programs, in my area, and I think it might be federal, but I'm not 100% sure. There's a health insurance counseling and advocacy program where you can meet with somebody like a counselor to help you pick a good plan. Do you have that in your state?

Martirosov: Yes. I think it's a statewide requirement. They're great resources for patients.

Witt: I could talk to you all day about this, but we have to wrap up. Any key points that you want to leave our listeners with or resources they should check out?

Martirosov: I would just belabor the point that I always belabor, which is if you don't feel comfortable using inhalers, how can you expect your patients to do it? Please educate yourself so that you can then educate your patients and make a world of difference.

Witt: I feel the same way about understanding Medicare. COPD is a mostly a chronic disease in people who are likely on Medicare. There are some exceptions, but I think it's so important to understand the basics of Medicare Part D so you can talk to patients about why their costs are what they are and help brainstorm with them about reducing costs. Thank you so much again, Amber. Today we've talked to Dr Martirosov about inhaler choice and barriers to use, including high cost of care, my secret favorite topic in medicine. There is nothing more I love then nerding-out to Medicare Part D. Thank you so much for joining us. Take a moment to download the Medscape app to listen and subscribe to this podcast series on COPD. This is Dr. Leah Witt for the Medscape InDiscussion Chronic Obstructive Pulmonary Disease podcast.

Resources

Global Strategy for Prevention, Diagnosis and Management of COPD: 2023 Report

Nebulized Therapies in COPD: Past, Present, and the Future

Advair

QVAR RediHaler

Asthma & Allergy Network

American Lung Association

Optimization of Patient-Specific Inhaler Regimens With the Use of the Aerosol Inhalation Monitor

Guiding Inspiratory Flow: Development of the In-Check DIAL G16, a Tool for Improving Inhaler Technique

The COPD Pocket Consultant Guide Mobile App

CoverMyMeds

GoodRX

Medicare Plan Compare

This transcript has been edited for clarity. For more episodes, download the Medscape app or subscribe to the podcast on Apple Podcasts, Spotify, or your preferred podcast provider.

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26Mar

Respiratory Inhaler Market to Surpass USD 27,779.9 Million by 2017, with CAGR of 4.2% | Marketresearch.biz

Posted by: admin Categories: PULMONARY DISEASES
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Marketresearch.biz reports that the Respiratory inhaler market is estimated to be valued at US$ 27,779.9 million in 2017, and is expected to register a CAGR of 4.2%.

Overview of the Respiratory Inhaler Market

The Respiratory Inhaler Market encompasses a diverse range of medical devices used for the delivery of medication directly to the lungs, providing relief and management for various respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis. Inhalers are essential tools in respiratory therapy, offering convenient and effective administration of bronchodilators, corticosteroids, and other respiratory medications. With the increasing prevalence of respiratory diseases worldwide and advancements in inhaler technology, the respiratory inhaler market is witnessing significant growth and innovation.

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Driving Factors of the Respiratory Inhaler Market

  • Rising Prevalence of Respiratory Diseases: The increasing incidence of respiratory conditions, such as asthma, COPD, and bronchiectasis, due to factors such as air pollution, smoking, and aging population, drives the demand for respiratory inhalers for symptom relief and disease management.
  • Technological Advancements in Inhaler Design: Ongoing advancements in inhaler technology, including the development of metered-dose inhalers (MDIs), dry powder inhalers (DPIs), and soft mist inhalers (SMIs), improve drug delivery efficiency, dose accuracy, and patient convenience, driving adoption and market growth.
  • Focus on Patient-Centric Care: There is a growing emphasis on personalized and patient-centric approaches to respiratory care, with inhaler devices designed to meet the specific needs and preferences of patients, such as ease of use, portability, and dose counters, enhancing patient adherence and treatment outcomes.
  • Expanding Geriatric Population: The aging population is more susceptible to respiratory diseases and comorbidities, driving demand for respiratory inhalers in geriatric care settings for the management of chronic respiratory conditions and exacerbations.
  • Increasing Healthcare Expenditure: Rising healthcare expenditure, coupled with favorable reimbursement policies for respiratory medications and devices, supports market growth by facilitating access to inhaler therapies and driving adoption rates among patients and healthcare providers.
  • Growing Awareness and Education Initiatives: Awareness campaigns, patient education programs, and advocacy efforts focused on respiratory health and disease management raise awareness about the importance of early diagnosis, adherence to treatment, and proper inhaler technique, driving demand for respiratory inhalers.

Restraining Factors of the Respiratory Inhaler Market

  • Regulatory Challenges and Compliance: Stringent regulatory requirements, including product approvals, labeling regulations, and manufacturing standards, pose challenges for market entry, product differentiation, and compliance with changing regulatory landscapes, impacting market dynamics and innovation.
  • Price Competition and Cost Constraints: Intense price competition among key players in the respiratory inhaler market, coupled with cost constraints within healthcare systems, may lead to pricing pressures, margin erosion, and limited investment in research and development, hindering market growth and innovation.
  • Technological Barriers and Accessibility: Technological complexities associated with some inhaler devices, coupled with limited access to healthcare infrastructure and resources in certain regions, may restrict patient access to advanced inhaler therapies and contribute to disparities in respiratory care outcomes.

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The Respiratory Inhaler Market report provides a comprehensive exploration of the sector, categorizing the market by type, application, and geographic distribution. This analysis includes data on market size, market share, growth trends, the current competitive landscape, and the key factors influencing growth and challenges. The research also highlights prevalent industry trends, market fluctuations, and the overall competitive environment.

This document offers a comprehensive view of the Global Respiratory Inhaler Market, equipping stakeholders with the necessary tools to identify areas for industry expansion. The report meticulously evaluates market segments, the competitive scenario, market breadth, growth patterns, and key drivers and constraints. It further segments the market by geographic distribution, shedding light on market leadership, growth trends, and industry shifts. Important market trends and transformations are also highlighted, providing a deeper understanding of the market’s complexities. This guide empowers stakeholders to leverage market opportunities and make informed decisions. Additionally, it provides clarity on the critical factors shaping the market’s trajectory and its competitive landscape.

Following Key Segments Are Covered in Our Report

Global respiratory inhaler segmentation by product type:

  • Dry Powder Inhalers
    • Single Unit Dose
    • Multi-Unit Dose
  • Metered Dose Inhalers
  • Nebulizers
    • Compressed
    • Mesh
    • Ultrasonic

Global respiratory inhaler segmentation by application:

  • Asthma
  • Chronic Obstructive Pulmonary Disease
  • Pulmonary Arterial Hypertension
  • Cystic Fibrosis

Global respiratory inhaler segmentation by technology:

Key Players in Respiratory Inhaler Market

  • GlaxoSmithKline PLC
  • AstraZeneca PLC
  • Boehringer Ingelheim International GmbH
  • Novartis AG
  • Mylan N.V.
  • Teva Pharmaceutical Industries Ltd.
  • Cipla Limited
  • Merck & Co., Inc.
  • SANOFI S.A.
  • Philips Healthcare

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Regional Analysis for Respiratory Inhaler Market

  • North America: North America leads the respiratory inhaler market with high prevalence of respiratory diseases such as asthma and COPD, driving demand for inhalation therapies and advanced drug delivery devices.
  • Europe: Europe follows suit, supported by favorable reimbursement policies and increasing adoption of inhalation medications.
  • Asia Pacific: The Asia Pacific region shows promising growth with rising pollution levels and increasing prevalence of respiratory disorders.
  • Middle East: Adoption is gradually increasing in the Middle East, driven by growing awareness of respiratory health issues and improving access to inhalation therapies.
  • Africa: Africa represents an emerging market with efforts to address respiratory diseases through expanding healthcare infrastructure and availability of inhalation medications.

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Growth Opportunities for Respiratory Inhaler Market

  • Increasing Respiratory Disorders: Rising prevalence of respiratory diseases such as asthma, COPD, and respiratory infections drives demand for respiratory inhaler devices and medications.
  • Technological Advancements: Innovation in inhaler device design, propellant technologies, and drug formulations improves drug delivery efficiency, patient adherence, and treatment outcomes.
  • Expanding Patient Demographics: Growing aging population, urbanization, and environmental pollution contribute to the increasing incidence of respiratory conditions, expanding the potential market for respiratory inhalers.
  • Emergence of Personalized Medicine: Advancements in pharmacogenomics and precision medicine approaches enable personalized treatment regimens tailored to patients’ genetic profiles and disease phenotypes.
  • Global Health Initiatives: Efforts to address respiratory health disparities, promote smoking cessation, and improve access to essential medicines drive market growth in developing regions.

Trending Factors for Respiratory Inhaler Market

  • Digital Health Integration: Integration of inhaler sensors, mobile applications, and electronic health records enables real-time monitoring of medication adherence, inhaler technique, and disease management, shaping market trends.
  • Biosimilar Competition: Introduction of biosimilar inhaler products and generic alternatives influences pricing dynamics, market competition, and product differentiation strategies.
  • Patient Education and Training: Emphasis on patient education, inhaler technique training, and self-management support programs improves medication adherence, therapeutic outcomes, and market acceptance of respiratory inhalers.
  • Environmental Sustainability: Growing focus on eco-friendly inhaler designs, recyclable materials, and reduced carbon footprint drives innovation in environmentally sustainable inhaler technologies and influences consumer preferences.
  • Regulatory Landscape: Regulatory approvals, labeling requirements, and post-market surveillance regulations for respiratory inhaler devices and medications impact market access, product development timelines, and commercialization strategies.

Our comprehensive Market research report endeavors to address a wide array of questions and concerns that stakeholders, investors, and industry participants might have. The following are the pivotal questions our report aims to answer:

Industry Overview:

  • What are the prevailing global trends in the Respiratory Inhaler Market?
  • How is the Respiratory Inhaler Market projected to evolve in the coming years? Will we see a surge or a decline in demand?

Product Analysis:

  • What is the anticipated demand distribution across various product categories within Respiratory Inhaler?
  • Which emerging products or services are expected to gain traction in the near future?

Financial Metrics:

  • What are the projections for the global Respiratory Inhaler industry in terms of capacity, production, and production value?
  • Can we anticipate the estimated costs, profits, Market share, supply and consumption dynamics?
  • How do import and export figures factor into the larger Respiratory Inhaler Market landscape?

Strategic Developments:

  • What strategic initiatives and movements are predicted to shape the industry in the medium to long run?

Pricing and Manufacturing:

  • Which factors majorly influence the end-price of Respiratory Inhaler products or services?
  • What are the primary raw materials and processes involved in manufacturing within the Respiratory Inhaler sector?

Market Opportunities:

  • What is the potential growth opportunity for the Respiratory Inhaler Market in the forthcoming years?
  • How might external factors, like the increasing use of Respiratory Inhaler in specific sectors, impact the Market’s overall growth trajectory?

Historical Analysis:

What was the estimated value of the Respiratory Inhaler Market in previous years, such as 2022?

Key Players Analysis:

  • Who are the leading companies and innovators within the Respiratory Inhaler Market?
  • Which companies are positioned at the forefront and why?

Innovative Trends:

  • Are there any fresh industry trends that businesses can leverage for additional revenue generation?

Market Entry and Strategy:

  • What are the recommended Market entry strategies for new entrants?
  • How should businesses navigate economic challenges and uncertainties in the Respiratory Inhaler Market?
  • What are the most effective Marketing channels to engage and penetrate the target audience?

Geographical Analysis:

  • How are different regions performing in the Respiratory Inhaler Market?
  • Which regions hold the most potential for future growth and why?

Consumer Behavior:

  • What are the current purchasing habits of consumers within the Respiratory Inhaler Market?
  • How might shifts in consumer behavior or preferences impact the industry?

Regulatory and Compliance Insights:

  • What are the existing and upcoming regulatory challenges in the Respiratory Inhaler industry?
  • How can businesses ensure consistent compliance?

Risk Analysis:

  • What potential risks and uncertainties should stakeholders be aware of in the Respiratory Inhaler Market?

External Impact Analysis:

  • How are external events, such as geopolitical tensions or global health crises (e.g., Russia-Ukraine War, COVID-19), influencing the Respiratory Inhaler industry’s dynamics?
  • This report is meticulously curated to provide a holistic understanding of the Respiratory Inhaler Market, ensuring that readers are well-equipped to make informed decisions.

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25Mar

AstraZeneca caps out-of-pocket costs of meds for certain patients

Posted by: admin Categories: PULMONARY DISEASES
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Out-of-pocket costs for AstraZeneca’s inhaled respiratory therapies — most of which are used for chronic obstructive pulmonary disease (COPD) — will be capped at $35 per month for eligible patients in the U.S. starting in June, the company announced in a press release.

This cap, likely to benefit most commercially insured patients, comes as an expansion of AstraZeneca’s savings program in the U.S. for its entire portfolio of approved inhaled respiratory therapies. This includes the COPD medications Symbicort (budesonide-formoterol), Bevespi Aerosphere (glycopyrronium/formoterol fumarate), and Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate), as well as an asthma treatment called Airsupra (albuterol and budesonide).

“AstraZeneca’s expanded savings programs build on our longstanding commitment to addressing barriers to access and affordability for patients living with respiratory diseases to ultimately help patients lead healthier lives,” said Pascal Soriot, CEO of AstraZeneca.

The company has a couple of different savings programs in place. The monthly cap comes as part of its co-pay savings program, which intends to help people with commercial health insurance pay less in out-of-pocket costs for their prescriptions.

Individuals on federal insurance programs (e.g. Medicare, Medicaid) are not eligible for this type of support due to government restrictions. But the company also offers the AZ&Me Prescription Savings Program to help people on federal insurance or who are uninsured to access its medications. Patients enrolled in this program typically receive their medications at no cost.

Recommended Reading

An illustration of a stamp of the word

Patients often must pay out-of-pocket costs despite commercial insurance

As of Jan. 1, AstraZeneca also “substantially reduced the list price” of Symbicort in the U.S., the company noted in the release. That price cut followed a decline in Symbicort sales, by 16%, late last year after the first generic version of the therapy, called Breyna, entered the U.S. market in the third quarter of 2023, according to a year-end fiscal report.

Generics, while containing the same active ingredient and held to equivalent safety and efficacy standards as the brand-name therapy, are usually offered at a lower price.

Viatris, which markets Breyna, also has a copay assistance program for commercially insured patients through which a monthly supply could cost as little as $20 in out-of-pocket costs. A patient assistance program also is available to help those with financial needs access Viatris’ medications at no charge.

AstraZeneca noted that it will continue to offer discounts and rebates to Symbicort’s list price to help ensure affordability for patients. The overall goal, the company states, is to make these inhaled treatments more accessible for “the most vulnerable patients” living with these conditions, including people who have insufficient or no health insurance.

We remain dedicated to addressing the need for affordability of our medicines, but the system is complex and we cannot do it alone. … It is critical that Congress bring together key stakeholders to help reform the healthcare system so patients can afford the medicines they need, not just today, but for the future.

Inhaled therapies are the cornerstone of treatment for COPD, in which inflammation causes damage to the lungs and makes it harder to breathe.

There are three main types of medications typically contained in these inhalers. These include long-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), and/or corticosteroids.

LAMAs and LABAs are bronchodilators, or medications that work to relax and open the airways to make breathing easier. Corticosteroids, meanwhile, are intended to reduce inflammation.

First approved in the U.S. as a maintenance therapy for COPD in 2009, Symbicort is a combination of a LABA bronchodilator (formoterol) and a corticosteroid (budesonide).

Approved in 2016, Bevespi also contains the LABA formoterol, as well as a LAMA called glycopyrrolate. Breztri, which combines all three of the ingredients found in Symbicort and Bevespi, was approved in 2020 as a COPD maintenance therapy. No generics are currently available for either of these two medications in the U.S.

“We remain dedicated to addressing the need for affordability of our medicines, but the system is complex and we cannot do it alone,” Soriot said.

“It is critical that Congress bring together key stakeholders to help reform the healthcare system so patients can afford the medicines they need, not just today, but for the future,” Soriot added.

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25Mar

No Smoking Please – Expert insights and recommendations on prioritizing lung health

Posted by: admin Categories: PHYSICAL REHABILITATION
Comments Off on No Smoking Please – Expert insights and recommendations on prioritizing lung health

Smoking was once considered to be a style statement in the form of cigars and hookahs as shown in various Hollywood and Bollywood movies. Though a statutory warning flashes with every such picture depicting smoking but unfortunately it is still increasing. The chemicals and toxins in tobacco smoke damage the delicate tissues of your lungs, leading to inflammation, irritation, and narrowing of the airways. Over time, this can cause permanent damage to the airways in your lungs, increasing your risk of developing serious lung disease.

by Dr. Pavan Yadav, Lead Consultant - Interventional Pulmonology & Lung Transplantation, Aster RV Hospital
 
Smoking was once considered to be a style statement in the form of cigars and hookahs as shown in various Hollywood and Bollywood movies. Though a statutory warning flashes with every such picture depicting smoking but unfortunately it is still increasing. The chemicals and toxins in tobacco smoke damage the delicate tissues of your lungs, leading to inflammation, irritation, and narrowing of the airways. Over time, this can cause permanent damage to the airways in your lungs, increasing your risk of developing serious lung disease.
 
Air pollution also increases the risk of lung infections like bronchitis and pneumonia. In all the Metropolitan cities and urban areas, its residents grapple with unique challenges impacting lung health. The city's rapid urbanization brings forth concerning issues like air pollution, industrial emissions, and vehicular exhaust, all of which contribute to respiratory issues. Moreover, Bangalore's lush flora adds to the pollen levels, triggering allergies and exacerbating respiratory concerns. Seasonal variations in air quality and construction dust further compound these challenges, making lung health a pressing concern for its inhabitants.
 
Misconceptions Around Smoking and Lung Health
Recently No Smoking Day was observed and it is vital to address common misconceptions surrounding smoking and lung health. Many mistakenly believe that "light" or "low tar" cigarettes are less harmful, or perceive hookahs and e-cigarettes as safe alternatives. However, nicotine's addictive nature and smoking's comprehensive harm to the body, not just the lungs, must be acknowledged. Moreover, awareness about the irreversibility of smoking-induced lung damage remains low. We do not have to wait for ‘No Smoking Day’ to create awareness about the ill-health smoking can cause. It's crucial to emphasize that quitting smoking is pivotal for improving lung health and overall well-being. Support is available for those ready to embark on this journey towards a healthier life.
 
The Impact of Smoking on Lung Health Trends
Smoking remains a significant factor in the prevalence of lung diseases, including Chronic Obstructive Pulmonary Disease (COPD) and lung cancer, among Bangalore's residents. Both direct smokers and those exposed to second-hand smoke face increased risks, underscoring the pervasive threat smoking poses to lung health. Beyond quitting smoking, Bangalore residents can take proactive measures to safeguard their lung health. Regular exercise, a diet rich in antioxidants, and avoiding exposure to pollutants are paramount. Additionally, wearing masks during high pollution days, using air purifiers indoors, and scheduling regular health check-ups can mitigate pollution-related lung damage.
 
Improving Lung Health for Former Smokers
For individuals who have smoked previously, prioritizing lung health entails quitting smoking and engaging in pulmonary rehabilitation. Breathing exercises and vigilant avoidance of environments with air pollutants or second-hand smoke exposure are crucial for maintaining and improving lung function. To mitigate the adverse effects of air pollution, Bangalore residents should stay informed about air quality indices and limit outdoor activities during high pollution levels. Using N95 masks, improving indoor air quality, and advocating for cleaner energy sources are indispensable strategies.
 
Government Initiatives and Public Health Programs
The Government of India, through initiatives like the National Tobacco Control Program (NTCP), educates the public about smoking dangers. Bangalore, equipped with robust healthcare infrastructure, offers smoking cessation clinics providing counseling, medication, and support for individuals aiming to quit smoking.
 
Advancements in Lung Health Treatment and Prevention
Recent advancements, such as lung transplantation and personalized medicine, offer hope for improved lung health outcomes. Additionally, developments in pulmonary rehabilitation contribute to better preventive measures against chronic lung conditions like severe asthma. Research indicates a correlation between smoking and the severity of COVID-19 cases. Smokers are more likely to develop severe disease and experience worse outcomes due to lung damage and compromised immune function.
 
Resources for Smoking Cessation and Lung Health Awareness
Bangalore residents seeking to quit smoking or learn more about lung health can avail themselves of resources like the National Tobacco Cessation Program, QUITLINE, mobile cessation programs, local hospitals' smoking cessation clinics, online platforms, and community support groups. To conclude, prioritizing lung health requires collective efforts, including smoking cessation, pollution mitigation, and awareness campaigns. By taking proactive steps and leveraging available resources, Bangalore residents can safeguard their lung health and overall well-being.
 



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25Mar

Study links e-cigarettes to incurable disease called ‘Popcorn Lung’

Posted by: admin Categories: PULMONARY DISEASES
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Study finds e-cigarettes linked to incurable disease "popcorn lung"

Study finds e-cigarettes linked to incurable disease "popcorn lung"

E-cigarettes are often touted as a safer alternative to traditional cigarettes, but according to a study released by the Harvard School of Public Health, they may just pose a different threat than their nicotine-filled counterparts.

According to the study, 75 percent of flavored e-cigarettes and their refill liquids were found to contain Diacetyl, "a flavoring chemical linked to cases of severe respiratory disease" such as the incurable condition called "Popcorn Lung."

SEE ALSO: With feds slow to act, states target e-cigarette sales to minors

According to Harvard, the condition otherwise known as bronchiolitis obliterans was "colloquially termed "Popcorn Lung" because it first appeared in workers who inhaled artificial butter flavor in microwave popcorn processing facilities."

But despite the name of the disease, there is absolutely nothing savory about it. Popcorn Lung is a debilitating and irreversible respiratory disease which causes "scarring in tiny air sacs in the lungs that lead to excessive coughing and shortness of breath" similar to that seen in people with chronic obstructive pulmonary disease.

Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD)

Image: Getty

In analyzing 51 different flavored e-cigarettes, author of the study Joseph Allen and his team found at least one of three top toxins — diacetyl, acetoin and 2,3-pentanedione — in 47 of the e-cigs. Not only that, "the amount of diacetyl in 39 of the e-cigs exceeded the amount that was able to be detected by the laboratory."

"Diacetyl and other related flavoring chemicals are used in many other flavors beyond butter-flavored popcorn, including fruit flavors, alcohol flavors, and candy flavored e-cigarettes," said Allen, assistant professor of exposure assessment science at Harvard.

He found this particularly disturbing because of the appeal fruity e-cigarettes such as "Cotton Candy, Fruit Squirts, and Cupcake" may have to young people.

Since e-cigarettes are a fairly new technology, the study's co-author David Christiani, Elkan Blout Professor of Environmental Genetics, warns that Popcorn Lung may be just the tip of the iceberg when it comes to the dangers e-cigs pose to their users:

Since most of the health concerns about e-cigarettes have focused on nicotine, there is still much we do not know about e-cigarettes. In addition to containing varying levels of the addictive substance nicotine, they also contain other cancer-causing chemicals, such as formaldehyde, and as our study shows, flavoring chemicals that can cause lung damage.

Based on that, it might be best to try and kick the habit ASAP.

More on the dangers of e-cigarettes:
Man severely injured after e-cigarette explodes in his mouth
An e-cigarette left this man in the hospital on a ventilator
FDA proposes first regulations for e-cigarettes

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25Mar

Engineered stone and respiratory health risks for workers in NSW and Australia-wide – Employee Benefits & Compensation

Posted by: admin Categories: PREVENTION & WELLBEING
Comments Off on Engineered stone and respiratory health risks for workers in NSW and Australia-wide – Employee Benefits & Compensation

Engineered stone, a popular choice for countertops, has proven
popular due to its aesthetic appeal, cost, durability, and
versatility. However, in recent years there has been focus on the
serious health concerns linked to engineered stone including
long-term respiratory illness and premature death. In this article,
we will delve into what engineered stone is, the serious
respiratory health problems it poses for workers, and the call for
the ban of its use in Australia.

What is engineered stone?

Engineered stone, often known by but not limited to brand names
like Caesarstone, Silestone, or Quantum Quartz, is a popular
material used for kitchen and bathroom countertops, as well as
other interior surfaces. It is made by combining crushed natural
stone, such as quartz, with polymer resins and pigments to create a
durable and attractive surface. The result is a versatile material
with a wide range of colours and patterns that mimics the look of
natural stone at a much cheaper cost, hence the popularity.

What exactly are the health risks linked to engineered
stone?

While engineered stone offers many advantages, there is a
notable downside associated with its production and fabrication.
Engineered stone contains a high concentration of crystalline
silica, a naturally occurring mineral found in quartz, which poses
a significant respiratory health risk when airborne. The fine dust
produced during the cutting, grinding, and polishing of engineered
stone surfaces can be inhaled by workers and lead to severe health
problems, including:

i. Silicosis –
prolonged exposure to respirable crystalline silica dust can lead
to silicosis, an irreversible and often debilitating lung disease.
Silicosis causes scarring of lung tissue, leading to symptoms such
as coughing, breathlessness, and increased susceptibility to
respiratory infections. There is no cure for silicosis and if
developed, life expectancy is diminished.

ii. Lung cancer – inhaling
crystalline silica over an extended period is associated with an
increased risk of lung cancer. Most cases are not curable and
significantly reduce a worker's life expectancy.

iii. Chronic Obstructive Pulmonary Disease
(COPD) – silica exposure can
contribute to the development of COPD, a progressive lung condition
which includes emphysema and chronic bronchitis and is
characterised by breathing difficulties and shortness of
breath.

Silica dust exposure also increases the risk of developing
chronic kidney disease, autoimmune disorders (such as scleroderma
and systemic lupus erythematosus) and other adverse health effects,
including an increased risk of activating latent tuberculosis, eye
irritation and eye damage. The risk posed by engineered stone is
being touted as the new asbestos in terms of the
health ramifications for workers in Australia.

Legislative amendments to the Work Health and Safety Act 2011 (NSW) and
SafeWork Australia's call for a national ban

In response to growing concern over the health risks associated
with engineered stone, the NSW government has previously introduced
amendments to the Work Health and Safety Act 2011 (NSW)
which were designed to safeguard the health and well-being of
workers in the engineered stone industry.

These measures included reduced exposure limits, mandatory
health assessments, improved monitoring, and compliance as well as
education and training, and dust control measures which required
employers to implement effective dust control measures, including
proper ventilation, wet cutting methods, and the use of suitable
personal protective equipment.

To date however, persons conducting a business in this industry,
workers and regulators have failed to ensure the health and safety
of all workers working with engineered stone. In particular, the
lack of effective monitoring and compliance, despite some smaller
and sporadic wins, remains a big issue within the industry.

SafeWork Australia (SWA) has called for a
complete ban of the use of engineered stone in Australia. It has
undertaken significant work since 2018 to improve WHS arrangements
to prevent dust diseases including silicosis. This has included
amendments to NSW WHS legislation, however in February 2023 WHS
ministers agreed to SWA's recommendations to address workplace
exposure to respirable crystalline silica through national
awareness and change in behaviour initiatives, and further
regulation for all materials across all industries (which includes
engineered stone).

SWA undertook extensive analysis and consultation on the impacts
of a prohibition on the use of engineered stone and provided its
decision in a report to WHS Ministers on 16 August 2023 for
their consideration. The expert analysis undertaken shows that dust
from engineered stone poses unique hazards, and there is no
evidence that lower silica engineered stone is safer to work with,
meaning there is no safe level of exposure for workers. SWA has
recommended a prohibition on the use of all engineered stone,
irrespective of the crystalline silica content. There is also a
recommendation of the introduction of a licensing scheme to ensure
appropriate controls are in place to protect worker health when
engineered stone already in place needs to be removed, repaired, or
modified.

Silicosis and dust diseases pose an unacceptable health risk to
workers in Australia, and it is important to note that there are
significant financial and non-financial costs associated with being
diagnosed with silicosis or a dust disease, including significant
physical and emotional harm, the reduced ability to work, reduced
quality of life and ultimately premature death of workers. There
are also significant costs to the public health system and in turn
our economy.

SWA recommends urgent government intervention, due to the
disproportionate number of silicosis cases in engineered stone
workers, the younger age of diagnosis of silicosis and dust related
diseases in engineered stone workers, and the impacts on workers,
their families, and the wider community. The decision to prohibit
the use of some or all engineered stone is a matter for WHS
ministers who will meet later this year. It is clear that while
engineered stone revolutionised interior design, the long-term
health risks for workers involved in its fabrication and
installation outweighs the gain.

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guide to the subject matter. Specialist advice should be sought
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24Mar

Lung disease patients waiting up to 10 years for diagnosis in poorer areas of England | Health

Posted by: admin Categories: PHYSICAL REHABILITATION
Comments Off on Lung disease patients waiting up to 10 years for diagnosis in poorer areas of England | Health

Ministers are being urged to roll out a better testing regime for one of the country’s biggest killers, with the most recent figures showing death rates for chronic obstructive pulmonary disease more than three times higher in some of the most deprived areas of the country.

More than 20,000 people a year in England die from chronic obstructive pulmonary disease. The most significant cause of COPD is smoking, but a significant proportion of cases are work-related, triggered by exposure to fumes, chemicals and dust at work.

Figures from the Office for National Statistics reveal that death rates from the disease are significantly higher in more deprived areas of the country including Wolverhampton, Rochdale and Blackpool. Death rates in Salford (82 per 100,000) are 3.9 times higher than in Bath (21 per 100,0000).

The NHS is rolling out targeted lung screening across England for people aged between 55 and 74 who are current or former smokers. The charity Asthma + Lung UK says the checks will identify many people who may have COPD, but there is no established protocol for them to be diagnosed and given appropriate treatment and support.

Dr Samantha Walker, interim chief executive at Asthma + Lung UK, said: “Once targeted lung health checks are fully rolled out, millions of people could be told they have an incurable lung disease like chronic obstructive pulmonary disease, but they won’t be given a firm diagnosis or signposted to the right support, which is simply unacceptable.

An X-ray of a patient’s lungs. Photograph: Douglas Sacha/Getty Images

“What we need to see is a national referral pathway in place for those people who show signs of having other lung conditions as part of this screening process to ensure that people with all suspected lung conditions get the diagnosis and treatments that they deserve. We know that people with lung disease will live better, fuller lives with an earlier diagnosis.”

A survey by the charity published in 2022 found that nearly one in four people with COPD waited more than five years to be diagnosed. About one in eight waited more than 10 years for a diagnosis. There is no cure for COPD, but lifestyle changes and disease management can help slow its progression. A spirometry test which shows how well the lungs are working is used to diagnose COPD. An investigation last year by the BMJ, the medical journal, found that some of the most deprived areas of England had no or limited access for spirometry.

Katy Brown, 66, a former nursery nurse from Portishead, Somerset, said she had suffered from breathlessness since 2019, but had not been diagnosed with COPD until October last year. “It literally takes your breath away,” said Brown. “It’s like someone is sitting on your chest.”

She said that once diagnosed, people could benefit from pulmonary rehabilitation, which provides exercises and advice on managing the condition.

Felicity Payne, 67, a language teacher, from Eastbourne, said exercise played an important role in managing the condition, with regular mile-long swims part of her regime since her diagnosis in 2016. “I never thought I would be able to do that several years on [from the diagnosis],” she said. “It has been a lifeline.”

A Department of Health and Social Care spokesperson said: “We are working to improve services for people with chronic conditions such as COPD so they can live longer, healthier lives.

“The Major Conditions Strategy will look at proposals for the improvement of health outcomes across the six groups of conditions that includes COPD responsible for over 60% of ill health and early death in England.”

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23Mar

An integrated metabo-lipidomics profile of induced sputum for the identification of novel biomarkers in the differential diagnosis of asthma and COPD | Journal of Translational Medicine

Posted by: admin Categories: PULMONARY DISEASES
Comments Off on An integrated metabo-lipidomics profile of induced sputum for the identification of novel biomarkers in the differential diagnosis of asthma and COPD | Journal of Translational Medicine

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    23Mar

    University of St. Gallen Researchers Add New Study Findings to Research in Chronic Obstructive Pulmonary Disease (Medication adherence halves COPD patients’ hospitalization risk – evidence from Swiss health insurance data): Lung Diseases and Conditions – Chronic Obstructive Pulmonary Disease – Insurance News

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    University of St. Gallen Researchers Add New Study Findings to Research in Chronic Obstructive Pulmonary Disease (Medication adherence halves COPD patients’ hospitalization risk - evidence from Swiss health insurance data): Lung Diseases and Conditions - Chronic Obstructive Pulmonary Disease - Insurance News | InsuranceNewsNet























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    22Mar

    Chinese Medical Journal Pulmonary and Critic

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    Chronic obstructive pulmonary disease (COPD) is a chronic lung disease with irreversible airflow limitation and a leading cause of death worldwide. COPD is characterized by chronic bronchitis and emphysema, and is associated with malnutrition, muscle weakness, and an increased risk of infection. Although pulmonary tests are considered as the gold standard for COPD diagnosis, they cannot detect early stages of COPD, leading to underdiagnosis. This emphasizes the need for specific biomarkers for early diagnosis, classification, and clinical interventions.

    Recent studies suggested that changes in lipids, amino acids, glucose, nucleotides, and microbial metabolites in lungs and intestine, can effectively diagnose early COPD. Metabolomics, a discipline that analyzes different metabolites from body fluids, has emerged as a prominent technique for COPD assessment. However, there are no studies that identify and summarize the metabolites that significantly change during COPD.

    A recent review by Dr. Wenqian Wu, Dr. Zhiwei Li, Dr. Tiantian Zhang, and Dr. Hongmei Zhao from the Peking Union Medical College, along with Dr. Yongqiang Wang from 302 Hospital of China Guizhou Aviation Industry Group, and Dr. Chuan Huang at the Chinese Academy of Medical Sciences, provided an in-depth account of the advances in metabolomics of COPD over the last five years, highlighting some potential diagnostic markers and therapeutic targets. Their study was made available online on December 8, 2023, and published in Volume 1, Issue 4 of the journal Chinese Medical Journal Pulmonary and Critical Care Medicine.

    Sharing the motivation behind their study, Dr. Tiantian Zhang and Dr. Hongmei Zhao explain, “In addition to altered metabolites from body fluids, increasing evidence has shown that metabolites from pulmonary and intestinal microbes could help us understand the pathogenesis of COPD and the complex regulation underlying this disease.”

    Many studies have reported that the three major nutrients, namely protein, lipids, and glucose, along with nucleotide metabolites are closely associated with COPD development and progression.

    They found that levels of lipids like sphingolipids and their metabolites, cholesterol, and high-density lipoprotein (HDL), are significantly changed in individuals with COPD. This leads to oxidative stress, inflammation, lipotoxicity, and thus impaired lung function. Various studies suggested that reversing abnormal lipid metabolism and administration of beneficial lipids, might alleviate COPD effects and cardiopulmonary comorbidities.

    Dysregulation of amino acid metabolism led to accumulation of harmful metabolites, such as desmosine, isodesmosine, and elastin peptide, which aggravate the damage to the lungs. Furthermore, COPD patients have abnormal levels of amino acids and reduced synthesis capacity of antioxidant carnosine. Some studies suggested that supplementation with amino acids and N-acetylcysteine might be able to regulate amino acid metabolism in COPD.

    Glucose metabolism is crucial for energy generation and triggering the immune system. However, this metabolism is dysfunctional in COPD patients resulting in chronic fatigue, muscle weakness and an impaired immune response to pathogens. Further investigation revealed that COPD patients have impaired nucleotide metabolism leading to abnormal levels of adenosine triphosphate (ATP), cyclic adenosine monophosphate (cAMP), and cyclic guanosine monophosphate (cGMP). Nucleotide metabolism impacts on metabolic processes and further studies are warranted to investigate the correlation between nucleotide metabolism and metabolism of lipids, amino acids, and glucose.

    Besides metabolic disorders, microorganisms and their metabolites also play a key role in COPD pathogenesis. Individuals with COPD are prone to microbial colonization in their lower respiratory tract. The authors found that both pulmonary and intestinal microbes and their metabolites invade and impact the lungs. Different studies have identified certain common bacteria associated with lung disorders - Streptococcus, Haemophilus influenzae (H. influenzae), Pseudomonas aeruginosa, Campylobacter, to name a few. H. influenzae forms biofilm in the lower airways that acts as a bacterial depot leading to recurrent infections, microbial resistance, evasion of host immune system. Although current studies mainly focus on the bacterial microbiome, fungi and viruses are equally important and demand further studies.

    Interestingly chronic lung disorders like COPD impair the gut membrane, increasing gut permeability, microbial movement, and endotoxin release resulting in gut dysbiosis (disease induced imbalance in microbial populations), and a weakened immune response. The intestinal microbiome of COPD patients consists predominantly of microorganisms that reduce lung function, further establishing the correlation between gut microbiome and COPD. On the other hand, gut microorganisms and their metabolites like short chain fatty acids might play a crucial role in alleviating COPD. Thus, gut microflora might be a potential marker for early diagnosis and treatment of COPD.

    Overall, this study suggested that efficient regulation of lipid, amino acid, glucose, and nucleotide metabolism along with pulmonary and gut microbial metabolism is essential for COPD management. Dietary modifications to a low-carbohydrate diet and increasing fiber, antioxidant, and vitamin uptake help in COPD prevention.

    Dr. Zhang and Dr. Zhao conclude by saying, “Dietary regulation prevents or suppresses respiratory infections by regulating the intestinal microenvironment, which is surprisingly effective in alleviating the symptoms of COPD. We emphasize that intensified dietary management may be among the most feasible methods to improve metabolism in the body.”

     

    ***

     

    Reference

    Titles of original papers: Advances in metabolomics of chronic obstructive pulmonary disease

    Journal: Chinese Medical Journal Pulmonary and Critical Care Medicine

    DOI: doi.org/10.1016/j.pccm.2023.10.001

    Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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    22Mar

    COPD Tips to Conserve Energy

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    Many people with chronic obstructive pulmonary disease (COPD) experience severe fatigue that can limit their ability to perform daily activities. A 2021 review found fatigue was a symptom of COPD in 17–95% of people, depending on the study.

    Researchers don’t know why severe fatigue affects people with COPD, but there’s a significant association with airflow limitation. As COPD can cause you to have less oxygen coming into the body, you might experience greater amounts of fatigue.

    If you have COPD, you may need to find new ways to do daily tasks that require less energy. Often, making simple changes consistently can help conserve energy.

    There’s research to back that up. A 2020 study found that implementing strategies from a 2-week energy conservation training program reduced the energy expenditure of people with COPD on daily tasks. Assistive devices, good breathing techniques, and ergonomics were all part of the program.

    This room-by-room home tour can help you identify ways to modify activities of daily living so you can conserve your energy. For people with COPD, this may mean avoiding reaching, lifting, and bending, as well as finding easier ways to perform tasks.

    If you have COPD, performing daily tasks such as dressing or cooking can leave you feeling fatigued and breathless. Finding ways to make these tasks easier can help you conserve your energy.

    Getting regular physical activity can also help with fighting fatigue and improving shortness of breath. But it’s important not to overdo it. A pulmonary rehabilitation program can help you find ways to stay active and perform daily tasks with less breathlessness.

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    22Mar

    Global Respiratory Disposables Market Share, Analysis And Forecast To 2031

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    (MENAFN- Straits Research) Respiratory disposables connect respiratory equipment like ventilators, nebulizers, and oxygen therapy devices. Respiratory disposables include disposable oxygen masks, disposable resuscitators, and disposable tubes. Healthcare workers wear disposable respiratory protective equipment during procedures to prevent them from spreading microorganisms, bodily fluids, and foreign particles. Treatment for respiratory conditions like asthma, sleep apnea, and chronic obstructive pulmonary disease is provided by respiratory disposables (COPD). In addition to preventing infections, they also lessen the financial strain on hospitals, save time, and boost demand.
    Market Dynamics
    Increasing Respiratory Illnesses Drive the Global Market
    In the coming years, it is projected that an increase in the incidence of respiratory diseases that impact the respiratory system will help the sector flourish. There will be 38% more cases of lung cancer worldwide by 2030. The substantial rise in the prevalence of respiratory disorders is also projected to drive up the price of respiratory disposables. Due to the anticipated increase in the prevalence of respiratory diseases, including asthma and COPD, the global market for respiratory disposables is expected to expand.
    Rising Number of Viruses Attacking the Respiratory System Creates Tremendous Opportunities
    Respiratory viruses are people's most frequent disease-inducing agents and have a significant global impact on morbidity and mortality. Common respiratory pathogens from different virus families are well-suited for efficient person-to-person transmission worldwide. The respiratory viruses that circulate most frequently as endemic or epidemic agents include the influenza virus, respiratory syncytial virus, parainfluenza viruses, metapneumovirus, rhinovirus, coronavirus, adenovirus, and bocavirus. The market for respiratory disposables is expected to increase significantly due to the outbreak of these viruses because these products help to prevent the transmission of infections from one person to another.
    Regional Analysis
    North America is the most significant shareholder in the global respiratory disposables market and is expected to grow at a CAGR of 9.3% during the forecast period. North America has a sizable growth opportunity due to the government's focus on improving the healthcare infrastructure. The U.S. gained the highest revenue share due to the rising demand for maintaining a higher standard of living, the availability of skilled workers, and significant market players. The prevalence of state-of-the-art healthcare facilities with qualified medical staff, rising disposable demand for respiratory products, and increasing incidences of respiratory diseases like lung cancer, asthma, and COPD all contribute significantly to North America's market growth.
    Europe is expected to grow at a CAGR of 9.5% generating USD 989.82 million during the forecast period. During the forecast period, the respiratory disposables market in European countries is anticipated to grow steadily due to consumer demand for better respiratory disposables and the substantial presence of key players like Medtronic Plc. and Air Liquide S.A. A rise in the prevalence of respiratory diseases, an increase in air pollution, and new product developments in respiratory disposables are also significant growth drivers in Europe. The availability of qualified professionals and the development of the healthcare infrastructure are two additional key growth drivers for the Europe respiratory disposables market.
    Key Highlights

    The global respiratory disposables market was valued at USD 1.49 billion in 2021. It is projected to reach USD 3.4 billion by 2030, growing at a CAGR of 9.6 % during the forecast period (2022–2030).
    Based on product, the global respiratory disposables market is bifurcated into laryngoscopes, tubes, breathing bags, masks, resuscitators, and others. The resuscitators segment is the highest contributor to the market and is expected to grow at a CAGR of 8.9% during the forecast period.
    Based on patient groups, the global respiratory disposables market is bifurcated into neonatal and pediatric, adult, and geriatric. The geriatric segment owns the highest market share and is expected to grow at a CAGR of 9.4% during the forecast period.
    Based on end-user, the global respiratory disposables market is bifurcated into hospitals, nursing homes, and clinics, trauma centers, and home care. The hospitals, nursing homes, and clinics segment is the highest contributor to the market and is expected to grow at a CAGR of 9.1% during the forecast period.
    North America is the most significant shareholder in the global respiratory disposables market and is expected to grow at a CAGR of 9.3% during the forecast period.

    Competitive Players
    The global respiratory disposables market's major key players are 3M, Air Liquide S.A., Allied Healthcare Products Inc., Ambu S/A, B. Braun SE, Chart Industries Inc, Drägerwerk AG & Co. KGaA, Fisher & Paykel Healthcare Corporation Limited, General Electric., Getinge AB, Hamilton Medical, Invacare Corporation, Koninklijke Philips N.V., Medtronic, Masimo Corporation, ResMed, Rotech Healthcare Inc., Smiths Group plc., and SunMed, Teleflex Incorporated.
    Market News

    In October 2022, Hamilton Medical offered comfort to patients with an NIV mask portfolio. For patients, Hamilton Medical and Pulmodyne partnered to offer various interfaces.
    In August 2022, ResMed pledged to invest EUR 30 million in Irish research and development. According to a ResMed study, COPD is the third-deadliest disease in the world and affects over 480 million people.

    Global
    Respiratory Disposables
    Market: Segmentation
    By Product

    Laryngoscope
    Tubes
    Breathing Bag
    Masks
    Resuscitator
    Others

    By Patient Group

    Neonatal and Pediatric
    Adult
    Geriatric

    By End-User

    Hospitals, Nursing Homes, and Clinics
    Trauma Centers
    Homecare

    By Regions

    North America
    Europe
    Asia-Pacific
    LAMEA

    MENAFN22032024004597010339ID1108010658


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    22Mar

    BLVR Significantly Improved Severe Emphysema Over 24 Months

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    Patients with severe emphysema experienced significant and durable clinical improvements over 24 months with bronchoscopic lung volume reduction (BLVR) using the Spiration Valve System (SVS), which maintained an acceptable safety profile, according to study findings published in the Annals of the American Thoracic Society.

    In the EMPROVE trial of patients with severe heterogeneous emphysema (ClinicalTrials.gov Identifier: NCT01812447), BLVR/SVS demonstrated improvements in lung function, dyspnea, and quality-of-life (QOL) over 24 months of use. For the current report, researchers evaluated follow-up data from patients enrolled in EMPROVE to assess BLVR/SVS efficacy and safety for patients’ second year of device use.

    EMPROVE, a prospective, open-label, randomized controlled trial, enrolled 172 patients at 31 sites across Canada and the United States from October 2013 to mid-December 2019.  Patients, who were at least 40 years of age, initially were assigned in a 2:1 ratio to the treatment group (n=113) and to a control group (n=59). After the initial 12 months of EMPROVE, 96 patients remained evaluable in the treatment group and 43 patients in the control group. After the 24-month follow-up period, 80 patients in the treatment group and 34 patients in the control group remained evaluable.

    At baseline, no between-group differences were discernible in participants’ high-resolution computed tomography, plethysmography, pulmonary function, or QOL.

    “

    The results of the EMPROVE study indicate a marked improvement in lung function, QOL, and dyspnea in patients in the SVS treatment group, which remained durable for at least 24 months.The results of the EMPROVE study indicate a marked improvement in lung function, QOL, and dyspnea in patients in the SVS treatment group, which remained durable for at least 24 months.

    The researchers found forced mean (SD) expiratory volume in 1 second (FEV1) improved significantly and continued across 24 months in the treatment group (n=71) compared with the control group (n=30) (-0.082L [0.156] vs 0.005L [0.163], respectively). In the treatment group, 19.7% (14/71) of patients showed FEV1 response at 24 months, although this was not statistically significant compared with the control group (P =.57).

    The St. George’s Respiratory Questionnaire and the COPD (chronic obstructive pulmonary disease) Assessment Test showed that significant improvement was maintained.

    The researchers noted the modified Medical Research Council dyspnea scale score indicated the treatment group experienced significantly less dyspnea vs the control group. No between-group differences were noted in adverse events at 24 months. Acute COPD exacerbation rates were similar (treatment group, 13.7% [14/102]; control group, 15.6% [7/45]). Pneumothorax rates were low (treatment group, 1.0% [1/102]; control group, 0.0% [0/45]).

    The researchers stated there were no occurrences of unexpected serious device-related adverse events (SAEs) between 12 and 24 months; however, 2 device-related deaths occurred from baseline to 12 months. Overall mortality rates at 24 months were 18% in the treatment group and 15% in the control group (P =.81). Patients who died at 24 months vs those who survived were older at baseline and had a significantly lower 6-minute-walk distance and poorer lung function at baseline.

    Study limitations include the unblinded design, which lead to potential bias that was reflected in the subjective parameters of the control group.

    “The results of the EMPROVE study indicate a marked improvement in lung function, QOL, and dyspnea in patients in the SVS treatment group, which remained durable for at least 24 months,” the researchers concluded. The study authors wrote, “The safety profile remains satisfactory, with minimal device-related issues in this longer follow-up period.”

    Disclosure: This research was supported by Olympus Corporation. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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    22Mar

    AstraZeneca to Initiate Trial for Triple-Combination Inhaled Therapy for Chronic Obstructive Pulmonary Disease

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    AstraZeneca has announced it will initiate a phase 3 trial to investigate the effect of the triple-combination inhaled therapy budesonide/glycopyrronium/formoterol fumarate (BGF [Breztri Aerosphere]) on severe cardiopulmonary outcomes, including death, with individuals who have chronic obstructive pulmonary disease (COPD) and elevated cardiopulmonary risk, according to a press release from the company.1

    Image Credit: mi_viri - stock.adobe.com

    “The 2024 GOLD Report highlights the treatment effect of non-pharmacologic interventions and inhaled triple combination therapies on mortality. The Report calls for a more proactive therapeutic approach to improve outcomes in COPD. If positive, the THARROS trial will provide critical evidence about the potential of single inhaler, triple combination therapy to reduce severe cardiopulmonary events and further advance treatment goals in COPD, including for patients with no history of exacerbations, for whom no evidence currently exists,” Fernando Martinez MD, MS, chief of the division of pulmonary and critical care medicine at Weill Cornell Medicine and New York-Presbyterian Hospital, said in the press release.1

    According to the CDC, the age-adjusted prevalence of COPD has remained unchanged from 2011 to 2022, with estimates higher for women across years. Further, the age-standardized COPD death rates in adults decreased from 1999 to 2021, with a smaller difference between men and women in 2021 compared with 2019, according to the data from the CDC.2

    The THARROS study will be the first prospective trial to investigate the potential of inhaled triple therapy to reduce cardiopulmonary events in COPD. The study will investigate death from respiratory and cardiac causes will be the severe cardiopulmonary outcome measures. The trial will be multi-centered and double blinded and include 5000 individuals with COPD who have cardiopulmonary risk. Patients will be aged 40 to 80 years old and will receive the triple combination therapy or dual bronchodilator therapy, glycopyrronium/formoterol fumarate, according to the press release.1

    Furthermore, the company has announced that the first participants have also been dosed in the ATHLOS phase 3 clinical trial, investigating the triple therapy drug compared to inhaled corticosteroids and long-acting β-agonist, budesonide/formoterol fumarate (Symbicort; AstraZeneca), or the placebo on cardiopulmonary parameters, including hyperinflation and exercise endurance time, according to the press release. This study will include 180 individuals aged 40 to 80 years old.1

    Key Takeaways

    1. The THARROS trial investigates the effect of Breztri Aerosphere (triple-combination therapy) on severe cardiopulmonary outcomes (including death) in high-risk COPD patients.
    2. These trials address the need for a more proactive approach to COPD treatment, potentially reducing severe cardiopulmonary events.
    3. Breztri is already approved for COPD maintenance treatment in many countries.

    BGF is currently approved to treat COPD in 75 countries, including the United States. The drug is indicated for the maintenance treatment of individuals with COPD. The most common adverse reactions included upper respiratory tract infection, pneumonia, back pain, oral candidiasis, influenza, muscle spasms, urinary tract infection, cough, sinusitis, and diarrhea, according to the press release.1

    “Large outcomes trials have transformed the management of cardiovascular diseases by enhancing our understanding of the potentially broad impact of therapies targeting those diseases. Current evidence already supports a proactive treatment approach in COPD. Now THARROS is seeking to provide first-of-its-kind evidence to support a strategy of comprehensive cardiopulmonary risk reduction with a triple therapy,” David Berg, MD, MPH, associated physician in cardiovascular and critical care medicine at Brigham and Women’s Hospital at Harvard Medical School, said in the press release.1

    References
    1. AstraZeneca announces initiation of THARROS – a Phase III clinical trial investigating the potential of Breztri to improve cardiopulmonary outcomes in people with COPD. News release. AstraZeneca. March 13, 2024. Accessed March 19, 2024. www.astrazeneca-us.com/media/press-releases/2024/astrazeneca-announces-initiation-of-tharros-a-phase-iii-clinical-trial-investigating-the-potential-of-breztri-to-improve-cardiopulmonary-outcomes-in-people-with-copd.html
    2. Centers for Disease Control and Prevention. Chronic Obstructive Pulmonary Disease: National Trends. Updated February 29, 2024. Accessed March 19, 2024. www.cdc.gov/copd/data-and-statistics/national-trends.html

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