NCT05204888 myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
| NCT ID | NCT05204888 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Temple University |
| Condition | COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 642 participants |
| Start Date | 2022-02-02 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 642 participants in total. It began in 2022-02-02 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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. 9. 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 10. Willing to record daily symptoms and pulse oximetry and heart rate on daily basis 11. 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 12. Able to read and communicate in English 13. Have a home environment suitable for myAirvo 3 use. 14. 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 Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Current self-reported chronic use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV) 2. A STOPBang Questionnaire score \> 5\* 3. Pregnancy or lactation 4. Treatment with another investigational drug or other intervention within the previous 30 days 5. Life expectancy less than 12 months due to COPD or other comorbid condition. 6. Recent upper airway surgery (within the previous month) 7. Recent head or neck trauma (within the previous month) 8. Inability to tolerate nasal prongs 9. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05204888 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05204888 currently recruiting?
Yes, NCT05204888 is actively recruiting participants. Contact the research team at Gerard.Criner@tuhs.temple.edu for enrollment information.
Where is the NCT05204888 trial being conducted?
This trial is being conducted at Birmingham, United States, Scottsdale, United States, Jacksonville, United States, Kissimmee, United States and 11 additional locations.
Who is sponsoring the NCT05204888 clinical trial?
NCT05204888 is sponsored by Temple University. The trial plans to enroll 642 participants.
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