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

Sponsored by Temple University

About this study

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.

Objectives: Primary Objective: To determine if HFNT delivered by myAirvo 3 increases the time to first moderate exacerbation orsevere exacerbation or all-cause mortality in patients with moderate to very severe COPD Secondary Objectives: To determine if HFNT delivered by myAirvo 3 1. increases the time to first severe exacerbation 2. increases the time to first exacerbation (moderate or severe) 3. reduces severe exacerbation frequency 4. reduces moderate and severe exacerbation frequency 5. reduces hospitalization duration 6. improves quality of life 7. reduces dyspnea 8. reduces PCO2 9. is safe and well tolerated 10. determine if any of the objectives are related to duration of daily HFNT use 11. Assess cost effectiveness of HFNT use Exploratory objectives: Develop objective definit…

Where this study is enrolling (25)

Show all 25 locations
Who can participate

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.

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Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.