RECRUITING

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

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Conditions

COPD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-02-02
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05204888

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.

Ages Eligible for Study:30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 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. 2. A STOPBang Questionnaire score \> 5\*
  3. 3. Pregnancy or lactation
  4. 4. Treatment with another investigational drug or other intervention within the previous 30 days
  5. 5. Life expectancy less than 12 months due to COPD or other comorbid condition.
  6. 6. Recent upper airway surgery (within the previous month)
  7. 7. Recent head or neck trauma (within the previous month)
  8. 8. Inability to tolerate nasal prongs
  9. 9. Requirement of oxygen greater than 15 L/min
  10. * 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.

Contacts and Locations

Study Contact

Gerard Criner, MD
CONTACT
215-707-8113
Gerard.Criner@tuhs.temple.edu
Michael Jacobs, PharmD
CONTACT
215-707-2242
Michael.jacobs@temple.edu

Study Locations (Sites)

UAB School of Medicine/Lung Health Center
Birmingham, Alabama, 35205
United States
University of Florida, Jacksonville
Jacksonville, Florida, 32209
United States
Alloy Clinical Research
Kissimmee, Florida, 34741
United States
NewGen Health Group
Miami, Florida, 33176
United States
Destiny Research
Palmetto Bay, Florida, 33157
United States
The Iowa Clinic
West Des Moines, Iowa, 50266
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
Mayo Clinic
Rochester, Minnesota, 55905
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
Jeanes Hospital
Philadelphia, Pennsylvania, 19111
United States
Temple University
Philadelphia, Pennsylvania, 19140
United States
Heights Hospital
Houston, Texas, 77008
United States
West Virginia Clinical and Translational Science Institute
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: Temple University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-02
Study Completion Date2027-03

Study Record Updates

Study Start Date2022-02-02
Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

  • COPD