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

medical-cross
COPD
user
All genders
person-wave 40-100
world
Recruiting now
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Overview
Principal Investigator: Nicholas Hill, MD

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 E, 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.

Study details
Inclusion Criteria
  • 1. Documented history of moderate to very severe COPD (GOLD stages II – IV, Grade E)
  • 2. ≥Greater than or equal to 10 pack-year history of smoking (former or current)
  • 3. History of a severe COPD exacerbation requiring hospitalization in the previous six weeks
Exclusion Criteria
  • 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. Treatment with another investigational drug or other intervention within the previous 30 days
  • 3. Life expectancy less than 12 months due to COPD or other comorbid condition
Study Requirements

1. Screen/enroll assessment: Obtain informed consent. Screen potential participants by inclusion and exclusion criteria; administer STOPBang Questionnaire, obtain demographics and smoking history, history and physical examination, mMRC, CAT, blood gases (venous and arterial), spirometry. 2. Baseline Assessment: Medication history, vital signs, BMI, dyspnea (BDI ), 6-MWD, SGRQ, EQ5D, SF-12 , PSQI, SRIQ, BODE Index, GOLD classification, teach and adjust HFNT settings (HFNT arm only) 3. Phone visits occur ib Day 7 and Day 15 after randomization and each month without clinic visits 4. Follow-up clinic visits at 3M, 6M, 12M and every 6 months after year 1 for a maximum of 2 years