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

A vizsgálat adatai

Ki végzi

Temple University

Azonosító

NCT05204888

A regiszteradat frissítve

2025. február 6.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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.

Kizáró feltételek: Current self-reported chronic use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV); Treatment with another investigational drug or other intervention within the previous 30 days; Recent upper airway surgery (within the previous month); Recent head or neck trauma (within the previous month); Requirement of oxygen greater than 15 L/min; subjects with a STOPBang questionnaire score of > 5 may be eligible if a recent sleep study (within the previous 3 months) shows the absence of obstructive sleep apnea or the subject has, or is at risk of OSA, but refuses to use an OSA device and all other eligibility criteria are met; Life expectancy less than 12 months due to COPD or other comorbid condition; An individual who meets any of the following criteria will be excluded from participation in this study:; A STOPBang Questionnaire score > 5*; Pregnancy or lactation; Inability to tolerate nasal prongs.

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.

ClinicalTrials.gov NCT05204888