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

Recruiting now · Not applicable

Conditions studied: COPD

In brief

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.

Key facts

Study ID

NCT05204888

Run by

Temple University

People needed

642

Starts

2022-02-02

Expected to finish

2027-03-01

Last updated by the study team

2025-02-06

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• UAB School of Medicine/Lung Health Center — Birmingham, Alabama, United States (enrolling)
• Honor Health — Scottsdale, Arizona, United States (enrolling)
• University of Florida, Jacksonville — Jacksonville, Florida, United States (enrolling)
• Alloy Clinical Research — Kissimmee, Florida, United States (enrolling)
• Reliable Research, Inc. — Miami, Florida, United States (enrolling)
• NewGen Health Group — Miami, Florida, United States (enrolling)
• Destiny Research — Palmetto Bay, Florida, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• The Iowa Clinic — West Des Moines, Iowa, United States (enrolling)
• University of Maryland - Baltimore — Baltimore, Maryland, United States (enrolling)
• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States (enrolling)
• Henry Ford Health — Detroit, Michigan, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Cincinnati VA Medical Center — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• St. Luke's University Health Network — Bethlehem, Pennsylvania, United States (enrolling)
• Clinical Research Associates of Central Pennsylvania — DuBois, Pennsylvania, United States (enrolling)
• Jeanes Hospital — Philadelphia, Pennsylvania, United States (enrolling)
• Temple University — Philadelphia, Pennsylvania, United States (enrolling)
• The University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• Respire Research Institute — Houston, Texas, United States (enrolling)
• The University of Vermont Medical Center, Inc — Burlington, Vermont, United States (enrolling)
• West Virginia Clinical and Translational Science Institute — Morgantown, West Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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