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

Description

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

COPD

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
COPD
Intervention / Treatment

-

Contacts and Locations

Birmingham

UAB School of Medicine/Lung Health Center, Birmingham, Alabama, United States, 35205

Jacksonville

University of Florida, Jacksonville, Jacksonville, Florida, United States, 32209

Kissimmee

Alloy Clinical Research, Kissimmee, Florida, United States, 34741

Miami

NewGen Health Group, Miami, Florida, United States, 33176

Palmetto Bay

Destiny Research, Palmetto Bay, Florida, United States, 33157

West Des Moines

The Iowa Clinic, West Des Moines, Iowa, United States, 50266

Burlington

Lahey Hospital and Medical Center, Burlington, Massachusetts, United States, 01805

Detroit

Henry Ford Health, Detroit, Michigan, United States, 48202

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Current self-reported chronic use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV)
  • 2. A STOPBang Questionnaire score \> 5\*
  • 3. Pregnancy or lactation
  • 4. Treatment with another investigational drug or other intervention within the previous 30 days
  • 5. Life expectancy less than 12 months due to COPD or other comorbid condition.
  • 6. Recent upper airway surgery (within the previous month)
  • 7. Recent head or neck trauma (within the previous month)
  • 8. Inability to tolerate nasal prongs
  • 9. 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.

Ages Eligible for Study

30 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Temple University,

Study Record Dates

2027-03