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myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
Sponsor: Temple University
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.
Official title: myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home - a Multi-center Randomized Controlled Trial
Key Details
Gender
All
Age Range
30 Years - Any
Study Type
INTERVENTIONAL
Enrollment
642
Start Date
2022-02-02
Completion Date
2027-03
Last Updated
2025-02-06
Healthy Volunteers
No
Conditions
Interventions
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.
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.
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