myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
Start Date
2/2/2022
Completion Date
3/1/2027
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.
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)
Eligibility Criteria
Age Range: 30 years to No maximum
Interventions
myAirvo3
Pulse oximeter
Conditions
Locations
UAB School of Medicine/Lung Health Center
Birmingham, Alabama 35205
United States
Honor Health
Scottsdale, Arizona 85258
United States
University of Florida, Jacksonville
Jacksonville, Florida 32209
United States
Alloy Clinical Research
Kissimmee, Florida 34741
United States
Reliable Research, Inc.
Miami, Florida 33175
United States
NewGen Health Group
Miami, Florida 33176
United States
Destiny Research
Palmetto Bay, Florida 33157
United States
University of Chicago
Chicago, Illinois 60637
United States
The Iowa Clinic
West Des Moines, Iowa 50266
United States
University of Maryland - Baltimore
Baltimore, Maryland 21201
United States
Tufts Medical Center
Boston, Massachusetts 02111
United States
Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
United States
Henry Ford Health
Detroit, Michigan 48202
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Cincinnati VA Medical Center
Cincinnati, Ohio 45220
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United States
St. Luke's University Health Network
Bethlehem, Pennsylvania 18102
United States
Clinical Research Associates of Central Pennsylvania
DuBois, Pennsylvania 15801
United States
Jeanes Hospital
Philadelphia, Pennsylvania 19111
United States
Temple University
Philadelphia, Pennsylvania 19140
United States
The University of Pittsburgh
Pittsburgh, Pennsylvania 15260
United States
Respire Research Institute
Houston, Texas 77094
United States
The University of Vermont Medical Center, Inc
Burlington, Vermont 05401
United States
West Virginia Clinical and Translational Science Institute
Morgantown, West Virginia 26506
United States
Ottawa Hospital Research Institute
Ottawa, Ontario K1H 8L6
Canada
The Research Institute of McGill University Health Centre
Montreal, Quebec City H3H 2R9
Canada