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

NCT05204888 | Recruiting DMC FDA Device

• 1 other identifier: 268447
• Study Type: interventional
• Target: 642
• Locations: 2 countries
• Sites: 27

Brief Summary

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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 to first moderate or severe COPD exacerbation

  1 year

Secondary Outcomes (14)

• Time to first severe exacerbation

  1 year

• Time to moderate or severe exacerbation

  1 year

• Severe exacerbation frequency

  1 year

• Moderate/severe exacerbation frequency

  1 year

• Hospital length of stay

  1 year

Study Arms (2)

Usual COPD care

ACTIVE COMPARATOR

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

Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator.

ACTIVE COMPARATOR

The intervention is the myAirvo 3 humidifier with integrated flow generator delivered through the Optiflow™ + Duet nasal cannula.

Device: myAirvo3

Interventions

myAirvo3 DEVICE

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.

Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator.

Pulse oximeter DEVICE

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.

Usual COPD care

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Current self-reported chronic use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV)
• A STOPBang Questionnaire score \> 5\*
• Pregnancy or lactation
• Treatment with another investigational drug or other intervention within the previous 30 days
• Life expectancy less than 12 months due to COPD or other comorbid condition.
• Recent upper airway surgery (within the previous month)
• Recent head or neck trauma (within the previous month)
• Inability to tolerate nasal prongs
• 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.

Sponsors & Collaborators

• Temple University: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (27)

UAB School of Medicine/Lung Health Center

Birmingham, Alabama, 35205, United States

RECRUITING

Honor Health

Scottsdale, Arizona, 85258, United States

RECRUITING

University of Florida, Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

Alloy Clinical Research

Kissimmee, Florida, 34741, United States

RECRUITING

Reliable Research, Inc.

Miami, Florida, 33175, United States

RECRUITING

NewGen Health Group

Miami, Florida, 33176, United States

RECRUITING

Destiny Research

Palmetto Bay, Florida, 33157, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

The Iowa Clinic

West Des Moines, Iowa, 50266, United States

RECRUITING

University of Maryland - Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Cincinnati VA Medical Center

Cincinnati, Ohio, 45220, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18102, United States

RECRUITING

Clinical Research Associates of Central Pennsylvania

DuBois, Pennsylvania, 15801, United States

RECRUITING

Jeanes Hospital

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

The University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

Respire Research Institute

Houston, Texas, 77094, United States

RECRUITING

The University of Vermont Medical Center, Inc

Burlington, Vermont, 05401, United States

RECRUITING

West Virginia Clinical and Translational Science Institute

Morgantown, West Virginia, 26506, United States

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

The Research Institute of McGill University Health Centre

Montreal, Quebec City, H3H 2R9, Canada

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gerard Criner, MD

CONTACT

215-707-8113; Gerard.Criner@tuhs.temple.edu

Stephanie Yerkes

CONTACT

215-707-2357; stephanie.yerkes@temple.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients assigned to the HFNT group will be provided a myAirvo 3 device. The myAirvo 3 is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces. The interface used in this trial is the Optiflow™ + Duet nasal cannula sized for patient comfort. Patients will also be provided with a pulse oximetry device that connects to the myAirvo 3 to record pulse oximetry and heart rate once daily after wearing the device for two minutes. Patients assigned to the control group will be provided with a pulse oximetry device to record pulse oximetry and heart rate once daily after using the pulse oximeter for two minutes as well as answering a respiratory questionnaire and input data into a smartphone adapted to be used as an electronic diary.

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 24, 2022
• Study Start: February 2, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (25); CA (2)