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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
642
For patients assigned to the HFNT intervention group, a myAirvo 3 device will be provided. The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 - 60 L/min depending on the patient interface. The myAirvo 3 is for patients in homes and long-term care facilities.
A pulse oximeter will be provided to measure heart rate and pulse oximetry; subjects will enter and transmit the data on the smartphone once daily before 11AM. Heart rate and pulse oximetry measures will be taken after wearing the device for approximately 2 minutes.
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.
Time to first moderate or severe COPD exacerbation
Time frame: 1 year
Time to first severe exacerbation
To determine if HFNT delivered by myAirvo 3 increases the time to first severe exacerbation
Time frame: 1 year
Time to moderate or severe exacerbation
To determine if HFNT delivered by myAirvo 3 increases the time to first exacerbation (moderate or severe)
Time frame: 1 year
Severe exacerbation frequency
To determine if HFNT delivered by myAirvo 3 reduces severe exacerbation frequency
Time frame: 1 year
Moderate/severe exacerbation frequency
To determine if HFNT delivered by myAirvo reduces moderate and severe exacerbation frequency
Time frame: 1 year
Hospital length of stay
To determine if HFNT delivered by myAirvo 3 reduces hospitalization duration
Time frame: 1 year
Quality of life - SF-12 questionnaire
To determine if HFNT delivered by myAirvo improves quality of life as measured by the SF-12
Time frame: 1 year
Quality of life - Severe Respiratory Insufficiency Questionnaire
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UAB School of Medicine/Lung Health Center
Birmingham, Alabama, United States
RECRUITINGHonor Health
Scottsdale, Arizona, United States
RECRUITINGUniversity of Florida, Jacksonville
Jacksonville, Florida, United States
RECRUITINGAlloy Clinical Research
Kissimmee, Florida, United States
RECRUITINGReliable Research, Inc.
Miami, Florida, United States
RECRUITINGNewGen Health Group
Miami, Florida, United States
RECRUITINGDestiny Research
Palmetto Bay, Florida, United States
RECRUITINGUniversity of Chicago
Chicago, Illinois, United States
RECRUITINGThe Iowa Clinic
West Des Moines, Iowa, United States
RECRUITINGUniversity of Maryland - Baltimore
Baltimore, Maryland, United States
RECRUITING...and 17 more locations
To determine if HFNT delivered by myAirvo improves quality of life as measured by the Severe Respiratory Insufficiency Questionnaire
Time frame: 1 year
Quality of life - Saint George's Respiratory Questionnaire
To determine if HFNT delivered by myAirvo improves quality of life as measured by the Saint George's Respiratory Questionnaire
Time frame: 1 year
Quality of life - Baseline Dyspnea Index and Transitional Dyspnea Index
To determine if HFNT delivered by myAirvo improves quality of life as measured by the EQ-5D questionnaire
Time frame: 1 year
Dyspnea
To determine if HFNT delivered by myAirvo reduces dyspnea as measured by the Baseline Dyspnea Index and Transitional Dyspnea Index
Time frame: 1 year
pCO2 reduction
To determine if HFNT delivered by myAirvo reduces pCO2
Time frame: 1 year
Adverse event reporting
To determine if HFNT delivered by myAirvo is safe and well tolerated
Time frame: 1 year
Correlations with average hours of use
To determine if any of the above outcomes are related to duration of daily HFNT use
Time frame: 1 year
Cost effectiveness
To assess the cost effectiveness of HFNT use in COPD
Time frame: 1 year