Who Is Eligible

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