RecruitingNot ApplicableNCT05204888

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

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


Sponsor

Temple University

Enrollment

642 participants

Start Date

Feb 2, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a high-flow nasal therapy device called myAirvo 3 — which delivers warm, humidified air through the nose — for COPD patients at home, to see if it reduces breathlessness, improves exercise tolerance, and prevents flare-ups. **You may be eligible if...** - You are 30 years or older - You have moderate to very severe COPD (GOLD stages II–IV) - You are a current or former smoker - You have significant breathlessness (MRC score of 2 or more, or CAT score of 10 or more) - Your breathing test results confirm COPD **You may NOT be eligible if...** - You have mild COPD (GOLD stage I) - You have significant other lung conditions not related to COPD - You are currently enrolled in another clinical study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEmyAirvo3

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.

DEVICEPulse 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.


Locations(27)

UAB School of Medicine/Lung Health Center

Birmingham, Alabama, United States

Honor Health

Scottsdale, Arizona, United States

University of Florida, Jacksonville

Jacksonville, Florida, United States

Alloy Clinical Research

Kissimmee, Florida, United States

Reliable Research, Inc.

Miami, Florida, United States

NewGen Health Group

Miami, Florida, United States

Destiny Research

Palmetto Bay, Florida, United States

University of Chicago

Chicago, Illinois, United States

The Iowa Clinic

West Des Moines, Iowa, United States

University of Maryland - Baltimore

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Henry Ford Health

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Cincinnati VA Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

Clinical Research Associates of Central Pennsylvania

DuBois, Pennsylvania, United States

Jeanes Hospital

Philadelphia, Pennsylvania, United States

Temple University

Philadelphia, Pennsylvania, United States

The University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Respire Research Institute

Houston, Texas, United States

The University of Vermont Medical Center, Inc

Burlington, Vermont, United States

West Virginia Clinical and Translational Science Institute

Morgantown, West Virginia, United States

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

The Research Institute of McGill University Health Centre

Montreal, Quebec City, Canada

View Full Details on ClinicalTrials.gov

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NCT05204888


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