Actively Recruiting
myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
Led by Temple University · Updated on 2025-02-06
642
Participants Needed
27
Research Sites
264 weeks
Total Duration
On this page
Sponsors
T
Temple University
Lead Sponsor
F
Fisher and Paykel Healthcare
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to follow all study procedures and be available for the study duration
- Male or female aged 30 years or older
- FEV1/FVC ratio less than 70% and FEV1 less than 80% (GOLD stages II to IV, Grade E), confirmed by spirometry
- Medical Research Council (MRC) dyspnea score of 2 or higher or COPD Assessment Test (CAT) score of 10 or higher
- Former, current, or never smoker (current smokers must not smoke while using supplemental oxygen or the myAirvo 3 device)
- History of a severe COPD exacerbation requiring hospitalization within the past six weeks
- Stable COPD after hospitalization with no parenteral therapy for 24 hours, inhaled bronchodilators less than every four hours, oxygen stopped for 24 hours (unless home oxygen indicated), safe ambulation, ability to eat and sleep without significant dyspnea, and understanding of medication administration
- Willing to use the myAirvo 3 device daily for at least 8 hours, preferably at night
- Willing to record daily symptoms, pulse oximetry, and heart rate
- For women of reproductive potential: use of effective contraception for at least 1 month before screening and during study participation
- Ability to read and communicate in English
- Home environment suitable for myAirvo 3 use
- Agreement to lifestyle considerations including refraining from smoking while using supplemental oxygen or the myAirvo 3 device
You will not qualify if you...
- Current chronic use of positive airway pressure therapy (CPAP or NPPV)
- STOPBang Questionnaire score greater than 5, unless a recent sleep study shows no obstructive sleep apnea or the subject refuses OSA device use but meets other criteria
- Pregnancy or lactation
- Treatment with another investigational drug or intervention within 30 days prior
- Life expectancy less than 12 months due to COPD or other conditions
- Recent upper airway surgery within the past month
- Recent head or neck trauma within the past month
- Unable to tolerate nasal prongs
- Requirement of oxygen greater than 15 L/min
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
UAB School of Medicine/Lung Health Center
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
Honor Health
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
University of Florida, Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
4
Alloy Clinical Research
Kissimmee, Florida, United States, 34741
Actively Recruiting
5
Reliable Research, Inc.
Miami, Florida, United States, 33175
Actively Recruiting
6
NewGen Health Group
Miami, Florida, United States, 33176
Actively Recruiting
7
Destiny Research
Palmetto Bay, Florida, United States, 33157
Actively Recruiting
8
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
9
The Iowa Clinic
West Des Moines, Iowa, United States, 50266
Actively Recruiting
10
University of Maryland - Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
11
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
12
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Actively Recruiting
13
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
14
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
15
Cincinnati VA Medical Center
Cincinnati, Ohio, United States, 45220
Actively Recruiting
16
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
17
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
18
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18102
Actively Recruiting
19
Clinical Research Associates of Central Pennsylvania
DuBois, Pennsylvania, United States, 15801
Actively Recruiting
20
Jeanes Hospital
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
21
Temple University
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
22
The University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Actively Recruiting
23
Respire Research Institute
Houston, Texas, United States, 77094
Actively Recruiting
24
The University of Vermont Medical Center, Inc
Burlington, Vermont, United States, 05401
Actively Recruiting
25
West Virginia Clinical and Translational Science Institute
Morgantown, West Virginia, United States, 26506
Actively Recruiting
26
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
27
The Research Institute of McGill University Health Centre
Montreal, Quebec City, Canada, H3H 2R9
Actively Recruiting
Research Team
G
Gerard Criner, MD
CONTACT
S
Stephanie Yerkes
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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