MyAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
- Conditions
- COPD
- Interventions
- Device: myAirvo3Device: Pulse oximeter
- Registration Number
- NCT05204888
- Lead Sponsor
- Temple University
- Brief 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.
- Detailed Description
Objectives:
Primary Objective: To determine if HFNT delivered by myAirvo 3 increases the time to first moderate exacerbation orsevere exacerbation or all-cause mortality in patients with moderate to very severe COPD
Secondary Objectives:
To determine if HFNT delivered by myAirvo 3
1. increases the time to first severe exacerbation
2. increases the time to first exacerbation (moderate or severe)
3. reduces severe exacerbation frequency
4. reduces moderate and severe exacerbation frequency
5. reduces hospitalization duration
6. improves quality of life
7. reduces dyspnea
8. reduces PCO2
9. is safe and well tolerated
10. determine if any of the objectives are related to duration of daily HFNT use
11. Assess cost effectiveness of HFNT use
Exploratory objectives:
Develop objective definitions of exacerbations of differing levels of severity based on myAirvo 3 device or electronic diary collected measures of heart rate, respiratory rate, oxygen saturation, and dyspnea measured by modified visual analog score.
Endpoints: Primary Endpoint: The time to first moderate or severe exacerbation or all-cause mortality.
Primary Safety Endpoint: All data on adverse events, including reported to be not, possibly, probably, or definitely related to the use of myAirvo 3 device.
Secondary Endpoints:
* Rate of severe exacerbation, rate of moderate and severe exacerbations,
* Time to moderate exacerbation, time to severe exacerbation, time to moderate or severe exacerbation
* Hospitalization durations, from per visit data
* Quality of life by St George's Respiratory Questionnaire and SF-12
* Dyspnea, calculated mMRC and TDI over time
* Hours of daily HFNT use
* Impact of hours of daily HFNT use on any outcome
* PCO2
* Assess patient phenotype most likely to benefit from HFNT.
* Assess cost effectiveness of HFNT use
Exploratory endpoints:
* Development of objective definitions of exacerbations of differing levels of severity based on myAirvo 3 device or electronic diary collected measures of heart rate, respiratory rate, oxygen saturation, and dyspnea measured by modified visual analog score.
* HFNT settings (flow rate and temperature)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 642
Not provided
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator. myAirvo3 The intervention is the myAirvo 3 humidifier with integrated flow generator delivered through the Optiflow™ + Duet nasal cannula. Usual COPD care Pulse oximeter 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
- Primary Outcome Measures
Name Time Method To determine if myAirvo 3 use increases the time to first moderate exacerbation/severe exacerbation (hospitalization)/all-cause mortality in patients with moderate to very severe COPD. 1 year Time to first moderate or severe COPD exacerbation
- Secondary Outcome Measures
Name Time Method Quality of life - Severe Respiratory Insufficiency Questionnaire 1 year To determine if HFNT delivered by myAirvo improves quality of life as measured by the Severe Respiratory Insufficiency Questionnaire
Quality of life - Saint George's Respiratory Questionnaire 1 year To determine if HFNT delivered by myAirvo improves quality of life as measured by the Saint George's Respiratory Questionnaire
Dyspnea 1 year To determine if HFNT delivered by myAirvo reduces dyspnea as measured by the Baseline Dyspnea Index and Transitional Dyspnea Index
pCO2 reduction 1 year To determine if HFNT delivered by myAirvo reduces pCO2
Adverse event reporting 1 year To determine if HFNT delivered by myAirvo is safe and well tolerated
Correlations with average hours of use 1 year To determine if any of the above outcomes are related to duration of daily HFNT use
Time to moderate or severe exacerbation 1 year To determine if HFNT delivered by myAirvo 3 increases the time to first exacerbation (moderate or severe)
Severe exacerbation frequency 1 year To determine if HFNT delivered by myAirvo 3 reduces severe exacerbation frequency
Moderate/severe exacerbation frequency 1 year To determine if HFNT delivered by myAirvo reduces moderate and severe exacerbation frequency
Hospital length of stay 1 year To determine if HFNT delivered by myAirvo 3 reduces hospitalization duration
Quality of life - Baseline Dyspnea Index and Transitional Dyspnea Index 1 year To determine if HFNT delivered by myAirvo improves quality of life as measured by the EQ-5D questionnaire
Cost effectiveness 1 year To assess the cost effectiveness of HFNT use in COPD
Time to first severe exacerbation 1 year To determine if HFNT delivered by myAirvo 3 increases the time to first severe exacerbation
Quality of life - SF-12 questionnaire 1 year To determine if HFNT delivered by myAirvo improves quality of life as measured by the SF-12
Trial Locations
- Locations (27)
UAB School of Medicine/Lung Health Center
🇺🇸Birmingham, Alabama, United States
Honor Health
🇺🇸Scottsdale, Arizona, United States
University of Florida, Jacksonville
🇺🇸Jacksonville, Florida, United States
Alloy Clinical Research
🇺🇸Kissimmee,, Florida, United States
Reliable Research, Inc.
🇺🇸Miami, Florida, United States
NewGen Health Group
🇺🇸Miami, Florida, United States
Destiny Research
🇺🇸Palmetto Bay, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
The Iowa Clinic
🇺🇸West Des Moines, Iowa, United States
University of Maryland - Baltimore
🇺🇸Baltimore, Maryland, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Lahey Hospital and Medical Center
🇺🇸Burlington, Massachusetts, United States
Henry Ford Health
🇺🇸Detroit, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Cincinnati VA Medical Center
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
St. Luke's University Health Network
🇺🇸Bethlehem, Pennsylvania, United States
Clinical Research Associates of Central Pennsylvania
🇺🇸DuBois, Pennsylvania, United States
Jeanes Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
The University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Respire Research Institute
🇺🇸Houston, Texas, United States
The University of Vermont Medical Center, Inc
🇺🇸Burlington, Vermont, United States
West Virginia Clinical and Translational Science Institute
🇺🇸Morgantown, West Virginia, United States
Ottawa Hospital Research Institute
🇨🇦Ottawa, Ontario, Canada
The Research Institute of McGill University Health Centre
🇨🇦Montréal, Quebec City, Canada