An interventional study of myAirvo3 and Pulse oximeter in COPD, sponsored by Temple University. Recruiting at 27 sites in 2 countries. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Temple University · Not applicable, Interventional, and Treatment
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
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:
Exploratory endpoints:
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's planned enrollment of 642 is above the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Temple University is the lead sponsor of 223 studies on the registry; 29 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
To be eligible to participate in this study, an individual must meet all the following criteria:
FEV1/FVC of \< 70% and an FEV1 of \< 80% (GOLD stages II - IV, Grade E)
Former smokers or current smokers and never-smokers are eligible for study inclusion
COPD in a stable state after hospitalization defined as:
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:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Requirement of oxygen greater than 15 L/min
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
Device: Pulse oximeter
The intervention is the myAirvo 3 humidifier with integrated flow generator delivered through the Optiflow™ + Duet nasal cannula.
Device: myAirvo3
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
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
Plan to share: No
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Pulmonary Disease, Chronic Obstructive →