myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
ConditionCOPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorTemple University
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- myAirvo3
- Pulse oximeter
Treatment groups
642 Participants
are divided into 2 treatment groupsSponsors and collaborators
Temple University
Lead sponsor
Fisher and Paykel Healthcare
Collaborator
Source ClinicalTrials.gov