Who Is Eligible
Inclusion Criteria
- Male or female, aged 30 years or greater
- 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
- 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.
- 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 ≤ 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 eight hours each day preferably at night following being shown and using the device
- Willing to record symptoms, pulse oximetry, and heart rate on a daily basis
- For females of reproductive potential: use of highly effective contraception for at least one month prior to screening and agreement to use such a method during study participation
- Able to read and communicate in English
- Have a home environment suitable for myAirvo 3 use.
- Agreement to adhere to lifestyle considerations throughout study duration
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria
- 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
- Recent head or neck trauma
- Inability to tolerate nasal prongs
- Requirement of oxygen greater than 15 L/min