myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
This study tests whether using a high-flow nasal therapy device called myAirvo 3 at home can help people with moderate to severe COPD feel better and breathe easier. Half of the participants will use the device along with their regular COPD medicines, while the other half will continue with their usual care only. The study will last 1-2 years to see if the device makes a real difference in how patients feel and their overall health.
Key Objective:This trial is testing whether adding high-flow nasal therapy at home can improve symptoms, quality of life, and reduce hospital visits in people with moderate to very severe COPD.
Who to Consider:People with moderate to very severe COPD (GOLD Stages II-IV) who are interested in trying a new home-based breathing therapy in addition to their current medications should consider enrolling.
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
To be eligible to participate in this study, an individual must meet all the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 30 years or greater 4. 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. 5. MRC ≥ 2 or CAT ≥ 10 6. 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 7. History of a severe COPD exacerbation requiring hospitalization in the previous six weeks 8. COPD in a stable state after hospitalization defined as: * Clinically stable condition and have had no parenteral therapy for 24 hours. * Inhaled bro