COPDF Nebulizer Consortium

There is currently inconclusive scientific evidence that nebulizer treatments increase transmission of coronaviruses (or other infectious disease agents). We believe that further research is needed to explore this very important topic related to coronavirus 2019 (COVID-19) and other airborne illnesses.

The COPD Foundation Nebulizer Consortium (CNC) aims to improve the understanding of any infection risks that may be associated with the administration of nebulized therapies and to develop solutions that ensure the safety of patients, caregivers, and health care providers.

What areas are we focusing on?

research

Research: Includes basic science, clinical and patient-focused projects, and publication of relevant findings.


education

Education: raise community awareness on nebulizer use in the COVID-19 environment and provide useful information to health care providers and those living with or caring for people with respiratory diseases.


guidance

Guidance: We will work with stakeholders to develop and promote guidelines for nebulizer use in various settings, including recommendations for health care providers.

Pillar Working Group Leads

Research

  • Academic Lead: Igor Barjaktarevic, MD, PhD
  • Industry Co-Lead: Karmon Johnson, PharmD

Education

  • Academic Lead: TBD
  • Industry Co-Lead: Lauren Cochran, PharmD

Guidance

  • Academic Lead: TBD
  • Patricia A Dailey, MSc, RRT

The COPDF will apply COPD360 tools including COPD360social, and COPD Patient-Powered Research Network (PPRN), PRAXIS and other community outreach methods to provide information on the use of nebulizers during the COVID-19 pandemic or other respiratory infections.

Examples of initiatives may include:

  • Collaborating with researchers assessing potential production of virus containing aerosols with nebulizer use in the inpatient, outpatient, and home settings.
  • Gathering data from patients, caregivers, and health care professionals through focus groups and/or surveys to understand concerns and impact, if any, on current medication use.
  • Developing educational materials designed to explain possible aerosol-mediated infection risks and risk mitigation strategies for nebulizer users.

Who are the members of the Consortium?

The COPD Foundation (COPDF) led Nebulizer Consortium is comprised of industry members, many scientific and academic field experts, and one government representative.


CNC Structure

CNC Structure

CNC COPDF members include:


  • David Mannino, MD, Co-Founder and Chief Medical Director (CNC COPDF Co-chair)
  • Sergio Martinez, Senior Manager of Research
  • Acknowledging past contribution from:
    • Elisha Malanga, BS, Corporate Relations Officer
    • Mike Hess, MPH, RRT, RPFT, Senior Director of Public Outreach and Education
    • Debora Merrill, MBA, Former Vice President, COPD Biomarkers Qualification Consortium and Project Management of the COPD Foundation
    • Julie Yates, BS, Former Senior Research Director of the COPD Foundation
    • Ruth Tal-Singer, PhD, Former President and CEO of the COPD Foundation

Patient Advocates:

  • Bonnie Truelsen, COPD Foundation Illinois State Captain
  • Diane Walsh, COPD Foundation Missouri State Captain
  • Acknowledging past contributions from:
    • Dan Kealing

Current CNC industry members include:

Theravance Logo

  • Lauren Cochran, PharmD (CNC Industry Co-chair)
  • Karmon Johnson, Pharm D

PARI Logo
  • Lisa Cambridge, MSHS, RRT
  • Rosina Ledermueller
  • Arshan Perera, PhD

Aerogen Logo
  • Patricia A Dailey, MSc, RRT
  • Michael Gentile, MBA, RRT, FAARC, FCCM

Monaghan Logo
  • Jason Suggett, PhD, BPharm, MBA
  • Dom Coppolo, MBA, RRT, FAARC, AE-C
  • Judy Schloss

Verona Pharma Logo
  • Blake Burnette
  • Candice Clay, PhD

Viatris Logo
  • Pranay P. Patel
  • Kim Gilchrist

Current CNC scientific/academic members include:

  • Phil Kuehl, PhD, Lovelace Biomedical
  • David C. Christiani, MD, MPH, MS, Harvard Medical School; Massachusetts General Hospital
  • Igor Barjaktarevic, MD, PhD, University of California Los Angeles
  • Jill Ohar, MD, Wake Forest University
  • Jie Li, PhD, RRT-NPS, RRT-ACCS, FAARC, Rush University
  • M. Brad Drummond, MD, MHS, University of North Carolina at Chapel Hill
  • Donald Mahler, MD, Valley Regional Hospital, Claremont, New Hampshire; Professor Emeritus at Dartmouth College
  • Rajiv Dhand, MD, FCCP, FACP, FAARC, FRSM, ATSF, University of Tennessee Health Sciences Center
  • Akshay Sood, MD, MPH, University of New Mexico School of Medicine
  • Arzu Ari, PhD, RRT, PT, CPFT, FAARC, FCCP, Texas State University
  • Sanjay Sethi, MD, University at Buffalo, State University of New York
  • Brian Carlin, MD, Sleep Medicine and Lung Health Consultants, Pittsburgh, PA
  • Donald Tashkin, MD, University of California Los Angeles
  • Lisa Saunders, BAS, RRT, TTS, Bronson Methodist Hospital
  • Matthew Dartt, BSRT, RRT-ACCS, University of California Los Angeles
  • Isaac N. Biney, MD, University of Tennessee Medical Center

Government liaison member:

  • Lewis J. Radonovich, MD, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, Resources for Human Development agency

Medical Professional Societies:

  • Sandra Han, AM, PMP, Director, Program Development, American College of Chest Physicians
  • Melissa Bustamante Patient Education Program Specialist, American College of Chest Physicians

References to publicly-available publications

For a list of references please contact the COPD Foundation at info@copdfoundation.org.

  • Viral Transmission of Respiratory Pathogens
  • Aerosol-Generating Procedures
  • Evidence Evaluating Coronavirus Transmission via Nebulization
  • Safe Administration of Nebulized Therapies in the COVID-19 Era
  • Aerosol-Generating Procedures
  • Evidence Evaluating Coronavirus Transmission via Nebulization
  • Safe Administration of Nebulized Therapies in the COVID-19 Era

Abbreviation Listplus

  • AARC: American Association for Respiratory Care
  • AGP: aerosol-generating procedure
  • AIIR: airborne infection isolation room (negative pressure room)
  • ATS: American Thoracic Society
  • BAN: breath-actuated nebulizer
  • BEN: breath-enhanced nebulizer
  • BiPAP: bilevel positive airway pressure
  • CDC: Centers for Disease Control and Prevention
  • CHEST: American College of Chest Physicians
  • CI: confidence interval
  • COVID-19: coronavirus disease 2019
  • CPAP: continuous positive airway pressure
  • CPR: cardiopulmonary resuscitation
  • DPI: dry-powder inhaler
  • H1N1: subtype of influenza A
  • HCP: healthcare professional
  • HCW: healthcare worker
  • HFNC: high flow nasal cannula
  • IDSA: Infectious Diseases Society of American
  • JN: jet nebulizer
  • MDI: metered-dose inhaler
  • MERS: Middle Eastern respiratory syndrome
  • MERS-CoV: Middle Eastern respiratory syndrome coronavirus
  • MIP: maximum inspiratory pressure
  • FEV1: forced expiratory volume in 1 second
  • N95: N95 respirator, respirator blocks at least 95% of very small test particles
  • NIH: National Institutes of Health
  • PAPR: powered air-purifying respirator
  • PIFR: peak inspiratory flow rate
  • PPE: personal protective equipment
  • Ro: R naught, indication of how contagious an infectious disease is
  • SARS: severe acute respiratory syndrome
  • SARS-CoV-1: severe acute respiratory syndrome coronavirus 1
  • SARS-CoV-2: severe acute respiratory syndrome coronavirus 2
  • SMI: soft-mist inhaler
  • VMN: vibrating mesh nebulizer
  • WHO: World Health Organization
  • μm: micrometer (micron)

What has the CNC achieved thus far?

COPD Foundation Nebulizer Consortium | Nebulizers, COVID-19, and You!

Facebook Live Event: "Nebulizers, COVID-19, and You!" (January 2021)

We know that nebulizers are the cornerstone of treatment for chronic lung conditions such as COPD, bronchiectasis, NTM, and asthma. The COVID-19 pandemic has brought about new questions and concerns about using nebulizers in health care clinics or hospitals and for some, even at home.

Watch this Facebook Live event by the COPD Foundation Nebulizer Consortium (CNC), where COPD Foundation's Mike Hess, RRT, David Mannino, MD and Janice Cotton, BS, MA (COPD Foundation Illinois State Captain) discussed nebulizer use in the age of COVID-19 and the formation of the CNC.


Survey 1: Aerosol Therapy Device Use During COVID-19 Survey (January - March 2021)

The Aerosol Therapy Device Use During COVID-19 Survey, was conducted by the CNC within the COPD Foundation's patient and medical communities (COPD360social, PPRN, Facebook, COPDF Praxis and CNC Newsletters). The survey consisted of 6 questions for patients/caregivers and 7 questions for healthcare providers.

The survey for patients inquired about the type of aerosol devices they used, where they used them and if they made changes to how they used aerosol devices due to concerns about COVID-19 transmission. Patients were also asked if they or someone they lived with had been diagnosed with COVID-19 and whether they had received a COVID-19 vaccine.

Healthcare providers were asked about the patient populations treated, aerosol devices used and whether their institutions considered aerosol therapy an “aerosol-generating procedure”. They were also asked if they had concerns regarding COVID-19 transmission during the use of aerosol-generating devices and if their institutions had made any changes to reduce the potential for COVID-19 transmission.

The CNC team is pleased to share a summary of the results.

Download


Helpful Information for Patients (May 2021)

Based on the Myths Busted for Clinicians piece CHEST and Theravance Biopharma released in March 2021, the COPD Foundation Nebulizer Consortium's Education pillar has developed an educational "Myths/Busted" infographic for patients.

This educational piece will provide key information for patients on the use of nebulization during the COVID-19 pandemic as well as responses to many common misconceptions regarding nebulization during the pandemic.

Download


Nebulization Safety for Patients and Health Workers | Helping the World to Breathe | COPD Foundation

Helping the World to Breathe (June - September 2021)

The COPD Foundation Nebulizer Consortium (CNC), in collaboration with the American Thoracic Society (ATS) have produced a 6-minute video titled Helping the World to Breathe, showcasing the multidisciplinary approach and collaboration of the CNC, as part of a video series program that will shine a light on the respiratory health community.

The CNC is pleased to share the video which includes interviews from the COPD Foundation and Industry Co-chairs, the patient perspective from a COPD Foundation State Captain, a respiratory therapist, and a community physician on improving the understanding of any infection risks that may be associated with the administration of nebulized therapy. Highlighting the CNC's goal of developing solutions that ensure the safety and education of patients, caregivers, and health care professionals.


INHALE Study (July 2023-Dec2024)

INHALE Study (July 2023-Dec2024)

The COPD Foundation and Dr. Donald A. Mahler, as part of the CNC received funding from Viatris to conduct a multi-site, obervational research study titled Impairments That Affect Correct Inhaler Use in COPD (INHALE).

The study is currently active and aims to: 1) determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with COPD and 2) assess the relationship of cognitive impairment and impaired manual dexterity with patient errors using their current pMDIs, SMIs, and/or DPIs.

NCT06135324


Guidance Manuscript (2022-2023)

Guidance Manuscript (2022-2023)

Manuscript: Guidance on Mitigating the Risk of Transmitting Respiratory Infections During Nebulization by the COPD Foundation Nebulizer Consortium, developed by the CNC team with guidance statements that would answer key questions surrounding medication delivery safety with nebulizers for patients and healthcare providers, was published in the CHEST Journal in November 2023.

Webinars and other deliverables are in progress as part of the dissemination plan.

DOI: https://doi.org/10.1016/j.chest.2023.11.013


Survey 2: Nebulizer Use Survey (October 2023 - March 2024)

Survey 2: Nebulizer Use Survey (October 2023 - March 2024)

The CNC developed a survey to assess real-world evidence about nebulizer use, led by Dr. Igor Barjaktarevic. The need for this data was generated as a follow-up to a Nebulizer Uptake in the SPIROMICS Cohort presentation from one of the monthly team meetings.

The survey was disseminated in 1Q2024. A summary of the survey data will be shared once it's available.


How can a company join the CNC?

The COPD Foundation has invited pharmaceutical companies and nebulizer device manufacturers to join this important effort. To join the CNC, a company will sign the CNC Agreement, pay a membership fee and join working groups of interest, aligned with interests and expertise. Members will share costs of CNC-approved projects.

Interested in joining the CNC?

Contact info@copdfoundation.org