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
Temple University
642 participants
Feb 2, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria27
- 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
Exclusion Criteria11
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Current self-reported chronic use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV)
- A STOPBang Questionnaire score \> 5\*
- Pregnancy or lactation
- Treatment with another investigational drug or other intervention within the previous 30 days
- Life expectancy less than 12 months due to COPD or other comorbid condition.
- Recent upper airway surgery (within the previous month)
- Recent head or neck trauma (within the previous month)
- Inability to tolerate nasal prongs
- 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.
Interventions
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.
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.
Locations(27)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05204888