MyAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home

February 5, 2025 updated by: Temple University

MyAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home - a Multi-center Randomized Controlled Trial

Parallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade D, Stages II-IV patients with moderate to very severe COPD at risk for moderate and severe exacerbations with a prior history of severe exacerbation requiring hospitalization within the past 6 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives:

Primary Objective: To determine if HFNT delivered by myAirvo 3 increases the time to first moderate exacerbation orsevere exacerbation or all-cause mortality in patients with moderate to very severe COPD

Secondary Objectives:

To determine if HFNT delivered by myAirvo 3

  1. increases the time to first severe exacerbation
  2. increases the time to first exacerbation (moderate or severe)
  3. reduces severe exacerbation frequency
  4. reduces moderate and severe exacerbation frequency
  5. reduces hospitalization duration
  6. improves quality of life
  7. reduces dyspnea
  8. reduces PCO2
  9. is safe and well tolerated
  10. determine if any of the objectives are related to duration of daily HFNT use
  11. Assess cost effectiveness of HFNT use

Exploratory objectives:

Develop objective definitions of exacerbations of differing levels of severity based on myAirvo 3 device or electronic diary collected measures of heart rate, respiratory rate, oxygen saturation, and dyspnea measured by modified visual analog score.

Endpoints: Primary Endpoint: The time to first moderate or severe exacerbation or all-cause mortality.

Primary Safety Endpoint: All data on adverse events, including reported to be not, possibly, probably, or definitely related to the use of myAirvo 3 device.

Secondary Endpoints:

  • Rate of severe exacerbation, rate of moderate and severe exacerbations,
  • Time to moderate exacerbation, time to severe exacerbation, time to moderate or severe exacerbation
  • Hospitalization durations, from per visit data
  • Quality of life by St George's Respiratory Questionnaire and SF-12
  • Dyspnea, calculated mMRC and TDI over time
  • Hours of daily HFNT use
  • Impact of hours of daily HFNT use on any outcome
  • PCO2
  • Assess patient phenotype most likely to benefit from HFNT.
  • Assess cost effectiveness of HFNT use

Exploratory endpoints:

  • Development of objective definitions of exacerbations of differing levels of severity based on myAirvo 3 device or electronic diary collected measures of heart rate, respiratory rate, oxygen saturation, and dyspnea measured by modified visual analog score.
  • HFNT settings (flow rate and temperature)

Study Type

Interventional

Enrollment (Estimated)

642

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa Hospital Research Institute
        • Contact:
        • Contact:
          • Shawn Aaron, MD
    • Quebec City
      • Montréal, Quebec City, Canada, H3H 2R9
        • Recruiting
        • The Research Institute of McGill University Health Centre
        • Contact:
        • Contact:
          • Marta Kaminska, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • UAB School of Medicine/Lung Health Center
        • Contact:
        • Contact:
          • Mark Dransfield, MD
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Honor Health
        • Contact:
        • Contact:
          • Rick Sue, MD
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida, Jacksonville
        • Contact:
        • Contact:
          • Mehdi Mirsaeidi, MD, MPH
      • Kissimmee,, Florida, United States, 34741
        • Recruiting
        • Alloy Clinical Research
        • Contact:
        • Contact:
          • Linda M Martinez, MD
      • Miami, Florida, United States, 33176
        • Recruiting
        • Newgen Health Group
        • Contact:
          • Phone Number: 305-892-1035
        • Contact:
          • Andrew Pastewski, MD
        • Contact:
          • Orlando Rodriguez, MD
      • Miami, Florida, United States, 33175
        • Recruiting
        • Reliable Research, Inc.
        • Contact:
        • Contact:
          • David Orta, MD
      • Palmetto Bay, Florida, United States, 33157
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
        • Contact:
          • Alejandra C Lastra, MD
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • The Iowa Clinic
        • Contact:
        • Contact:
          • Matthew Trump, DO
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland - Baltimore
        • Contact:
        • Contact:
          • Jennifer So, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Contact:
        • Contact:
          • Nicholas Hill, MD
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • Lahey Hospital and Medical Center
        • Contact:
        • Contact:
          • Victor Pinto-Plata, MD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Contact:
          • Zainab A Bhura, MBBS
          • Phone Number: 313-524-4147
        • Contact:
          • Jovica Veljanovski, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Contact:
        • Contact:
          • Nathaniel Gaeckle, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • Cincinnati VA Medical Center
        • Contact:
        • Contact:
          • Robert Burkes, MD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Contact:
          • Vickram Tejwani, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Wexner Medical Center
        • Contact:
        • Contact:
          • Philip Diaz, MD
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18102
        • Recruiting
        • St. Luke's University Health Network
        • Contact:
        • Contact:
          • Joseph Ramzy, MD
      • DuBois, Pennsylvania, United States, 15801
        • Recruiting
        • Clinical Research Associates of Central Pennsylvania
        • Contact:
          • Sandeep Bansal, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19140
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Jeanes Hospital
        • Contact:
          • Andrew Gangemi, MD
      • Pittsburgh, Pennsylvania, United States, 15260
        • Recruiting
        • The University of Pittsburgh
        • Contact:
          • Frank Sciurba, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77094
        • Recruiting
        • Respire Research Institute
        • Contact:
        • Contact:
          • Murtuza Ahmed, MD
    • Vermont
      • Burlington, Vermont, United States, 05401
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia Clinical and Translational Science Institute
        • Contact:
        • Contact:
          • Rachel Leonard, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

To be eligible to participate in this study, an individual must meet all the following criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged 30 years or greater

  4. FEV1/FVC of < 70% and an FEV1 of < 80% (GOLD stages II - IV, Grade E)

    • Spirometry performed during the screening visit will be used to confirm GOLD stage. A prior spirometric test within the past 6 months can be substituted if available.

  5. MRC ≥ 2 or CAT ≥ 10

  6. Former smokers or current smokers and never-smokers are eligible for study inclusion

    • Current smokers must refrain from smoking when using supplemental oxygen or the myAirvo-3 device

  7. History of a severe COPD exacerbation requiring hospitalization in the previous six weeks

  8. COPD in a stable state after hospitalization defined as:

    • Clinically stable condition and have had no parenteral therapy for 24 hours.
    • Inhaled bronchodilators are required less than four-hourly.
    • Oxygen delivery has ceased for 24 hours (unless home oxygen is indicated).
    • If previously able, the patient is ambulating safely and independently, and performing activities of daily living.
    • The patient can eat and sleep without significant episodes of dyspnea.
    • The patient or caregiver understands and can administer medications.
    • Follow-up and home care arrangements (e.g., home oxygen, homecare, Meals on Wheels, community nurse, allied health, GP, specialist) have been completed.
  9. Willing to adhere to the daily use of the myAirvo 3 regimen for at least 8 hours each day preferably at night following being shown and using the device
  10. Willing to record daily symptoms and pulse oximetry and heart rate on daily basis

  11. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

    Highly effective contraception is defined as:

    • A tubal ligation:
    • An approved hormonal contraceptive such as oral contraceptives, emergency contraception used as directed, patches, implants, injections, rings or intrauterine devices
  12. Able to read and communicate in English
  13. Have a home environment suitable for myAirvo 3 use.
  14. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration - refraining from smoking while receiving supplemental oxygen or the myAirvo-3 device

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Current self-reported chronic use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV)
  2. A STOPBang Questionnaire score > 5*
  3. Pregnancy or lactation
  4. Treatment with another investigational drug or other intervention within the previous 30 days
  5. Life expectancy less than 12 months due to COPD or other comorbid condition.
  6. Recent upper airway surgery (within the previous month)
  7. Recent head or neck trauma (within the previous month)
  8. Inability to tolerate nasal prongs

  9. Requirement of oxygen greater than 15 L/min

    • subjects with a STOPBang questionnaire score of > 5 may be eligible if a recent sleep study (within the previous 3 months) shows the absence of obstructive sleep apnea or the subject has, or is at risk of OSA, but refuses to use an OSA device and all other eligibility criteria are met.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual COPD care
The intervention : A pulse oximeter to record heart rate and pulse oximetry on a daily basis will be provided. A smart phone and charger will also be provided to answer a short questionnaire that queries daily respiratory symptoms plus enter heart rate and pulse oximetry data
Device: Pulse oximeter
A pulse oximeter will be provided to measure heart rate and pulse oximetry; subjects will enter and transmit the data on the smartphone once daily before 11AM. Heart rate and pulse oximetry measures will be taken after wearing the device for approximately 2 minutes.
Active Comparator: Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator.
The intervention is the myAirvo 3 humidifier with integrated flow generator delivered through the Optiflow™ + Duet nasal cannula.
Device: myAirvo3
For patients assigned to the HFNT intervention group, a myAirvo 3 device will be provided. The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 - 60 L/min depending on the patient interface. The myAirvo 3 is for patients in homes and long-term care facilities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine if myAirvo 3 use increases the time to first moderate exacerbation/severe exacerbation (hospitalization)/all-cause mortality in patients with moderate to very severe COPD.
Time Frame: 1 year
Time to first moderate or severe COPD exacerbation
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first severe exacerbation
Time Frame: 1 year
To determine if HFNT delivered by myAirvo 3 increases the time to first severe exacerbation
1 year
Time to moderate or severe exacerbation
Time Frame: 1 year
To determine if HFNT delivered by myAirvo 3 increases the time to first exacerbation (moderate or severe)
1 year
Severe exacerbation frequency
Time Frame: 1 year
To determine if HFNT delivered by myAirvo 3 reduces severe exacerbation frequency
1 year
Moderate/severe exacerbation frequency
Time Frame: 1 year
To determine if HFNT delivered by myAirvo reduces moderate and severe exacerbation frequency
1 year
Hospital length of stay
Time Frame: 1 year
To determine if HFNT delivered by myAirvo 3 reduces hospitalization duration
1 year
Quality of life - SF-12 questionnaire
Time Frame: 1 year
To determine if HFNT delivered by myAirvo improves quality of life as measured by the SF-12
1 year
Quality of life - Severe Respiratory Insufficiency Questionnaire
Time Frame: 1 year
To determine if HFNT delivered by myAirvo improves quality of life as measured by the Severe Respiratory Insufficiency Questionnaire
1 year
Quality of life - Saint George's Respiratory Questionnaire
Time Frame: 1 year
To determine if HFNT delivered by myAirvo improves quality of life as measured by the Saint George's Respiratory Questionnaire
1 year
Quality of life - Baseline Dyspnea Index and Transitional Dyspnea Index
Time Frame: 1 year
To determine if HFNT delivered by myAirvo improves quality of life as measured by the EQ-5D questionnaire
1 year
Dyspnea
Time Frame: 1 year
To determine if HFNT delivered by myAirvo reduces dyspnea as measured by the Baseline Dyspnea Index and Transitional Dyspnea Index
1 year
pCO2 reduction
Time Frame: 1 year
To determine if HFNT delivered by myAirvo reduces pCO2
1 year
Adverse event reporting
Time Frame: 1 year
To determine if HFNT delivered by myAirvo is safe and well tolerated
1 year
Correlations with average hours of use
Time Frame: 1 year
To determine if any of the above outcomes are related to duration of daily HFNT use
1 year
Cost effectiveness
Time Frame: 1 year
To assess the cost effectiveness of HFNT use in COPD
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

Fisher and Paykel Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 268447

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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