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

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:

∙ To be eligible to participate in this study, an individual must meet all the following criteria:

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Male or female, aged 30 years or greater

• FEV1/FVC of \< 70% and an FEV1 of \< 80% (GOLD stages II - IV, Grade E)

• • Spirometry performed during the screening visit will be used to confirm GOLD stage. A prior spirometric test within the past 6 months can be substituted if available.

• MRC ≥ 2 or CAT ≥ 10

• Former smokers or current smokers and never-smokers are eligible for study inclusion

• • Current smokers must refrain from smoking when using supplemental oxygen or the myAirvo-3 device

• History of a severe COPD exacerbation requiring hospitalization in the previous six weeks

• COPD in a stable state after hospitalization defined as:

‣ Clinically stable condition and have had no parenteral therapy for 24 hours.

⁃ Inhaled bronchodilators are required less than four-hourly.

⁃ Oxygen delivery has ceased for 24 hours (unless home oxygen is indicated).

⁃ If previously able, the patient is ambulating safely and independently, and performing activities of daily living.

⁃ The patient can eat and sleep without significant episodes of dyspnea.

⁃ The patient or caregiver understands and can administer medications.

⁃ Follow-up and home care arrangements (e.g., home oxygen, homecare, Meals on Wheels, community nurse, allied health, GP, specialist) have been completed.

• Willing to adhere to the daily use of the myAirvo 3 regimen for at least 8 hours each day preferably at night following being shown and using the device

⁃ Willing to record daily symptoms and pulse oximetry and heart rate on daily basis

⁃ For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

⁃ Highly effective contraception is defined as:

‣ A tubal ligation:

‣ An approved hormonal contraceptive such as oral contraceptives, emergency contraception used as directed, patches, implants, injections, rings or intrauterine devices

⁃ Able to read and communicate in English

⁃ Have a home environment suitable for myAirvo 3 use.

⁃ Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration - refraining from smoking while receiving supplemental oxygen or the myAirvo-3 device

Locations
United States
Alabama
UAB School of Medicine/Lung Health Center
RECRUITING
Birmingham
Arizona
Honor Health
RECRUITING
Scottsdale
Florida
University of Florida, Jacksonville
RECRUITING
Jacksonville
Alloy Clinical Research
RECRUITING
Kissimmee
NewGen Health Group
RECRUITING
Miami
Reliable Research, Inc.
RECRUITING
Miami
Destiny Research
RECRUITING
Palmetto Bay
Iowa
The Iowa Clinic
RECRUITING
West Des Moines
Illinois
University of Chicago
RECRUITING
Chicago
Massachusetts
Tufts Medical Center
RECRUITING
Boston
Lahey Hospital and Medical Center
RECRUITING
Burlington
Maryland
University of Maryland - Baltimore
RECRUITING
Baltimore
Michigan
Henry Ford Health
RECRUITING
Detroit
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Ohio
Cincinnati VA Medical Center
RECRUITING
Cincinnati
Cleveland Clinic Foundation
RECRUITING
Cleveland
Ohio State University Wexner Medical Center
RECRUITING
Columbus
Pennsylvania
St. Luke's University Health Network
RECRUITING
Bethlehem
Clinical Research Associates of Central Pennsylvania
RECRUITING
Dubois
Jeanes Hospital
RECRUITING
Philadelphia
Temple University
RECRUITING
Philadelphia
The University of Pittsburgh
RECRUITING
Pittsburgh
Texas
Respire Research Institute
RECRUITING
Houston
Vermont
The University of Vermont Medical Center, Inc
RECRUITING
Burlington
West Virginia
West Virginia Clinical and Translational Science Institute
RECRUITING
Morgantown
Other Locations
Canada
The Research Institute of McGill University Health Centre
RECRUITING
Montreal
Ottawa Hospital Research Institute
RECRUITING
Ottawa
Contact Information
Primary
Gerard Criner, MD
Gerard.Criner@tuhs.temple.edu
215-707-8113
Backup
Stephanie Yerkes
stephanie.yerkes@temple.edu
215-707-2357
Time Frame
Start Date: 2022-02-02
Estimated Completion Date: 2027-03
Participants
Target number of participants: 642
Treatments
Active_comparator: Usual COPD care
The intervention : A pulse oximeter to record heart rate and pulse oximetry on a daily basis will be provided. A smart phone and charger will also be provided to answer a short questionnaire that queries daily respiratory symptoms plus enter heart rate and pulse oximetry data
Active_comparator: Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator.
The intervention is the myAirvo 3 humidifier with integrated flow generator delivered through the Optiflow™ + Duet nasal cannula.
Sponsors
Leads: Temple University
Collaborators: Fisher and Paykel Healthcare

This content was sourced from clinicaltrials.gov