myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home - a Multi-center Randomized Controlled Trial
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.
∙ To be eligible to participate in this study, an individual must meet all the following criteria:
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 30 years or greater
• 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.
• MRC ≥ 2 or CAT ≥ 10
• 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
• History of a severe COPD exacerbation requiring hospitalization in the previous six weeks
• COPD in a stable state after hospitalization defined as:
‣ Clinically stable condition and have had no parenteral therapy for 24 hours.
⁃ Inhaled bronchodilators are required less than four-hourly.
⁃ Oxygen delivery has ceased for 24 hours (unless home oxygen is indicated).
⁃ If previously able, the patient is ambulating safely and independently, and performing activities of daily living.
⁃ The patient can eat and sleep without significant episodes of dyspnea.
⁃ The patient or caregiver understands and can administer medications.
⁃ Follow-up and home care arrangements (e.g., home oxygen, homecare, Meals on Wheels, community nurse, allied health, GP, specialist) have been completed.
• Willing to adhere to the daily use of the myAirvo 3 regimen for at least 8 hours each day preferably at night following being shown and using the device
⁃ Willing to record daily symptoms and pulse oximetry and heart rate on daily basis
⁃ 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:
‣ A tubal ligation:
‣ An approved hormonal contraceptive such as oral contraceptives, emergency contraception used as directed, patches, implants, injections, rings or intrauterine devices
⁃ Able to read and communicate in English
⁃ Have a home environment suitable for myAirvo 3 use.
⁃ Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration - refraining from smoking while receiving supplemental oxygen or the myAirvo-3 device