NCT05204888

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 642 (estimated)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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)

Conditions

• COPD

Interventions

Type	Name	Description
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.
DEVICE	Pulse oximeter	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.

Timeline

• Start date: 2022-02-02
• Primary completion: 2027-01-01
• Completion: 2027-03-01
• First posted: 2022-01-24
• Last updated: 2025-02-06

Locations

27 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study