Clinical Research Details

Clinical Research

myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD patients in the home – a multi-center randomized controlled trial

Study Description

The purpose of this research is to learn if home use of high flow nasal therapy (HFNT) increases the time to rehospitalization in patients with chronic obstructive pulmonary disease (COPD). You will be randomly assigned to one of two groups. One group will receive usual medical care for COPD.  The other group will receive usual medical care for COPD and use a high-flow nasal therapy device for a minimum of 8 hours daily.  You will have up to six clinic visits and monthly phone calls.  You will complete daily COPD symptom reports. Taking part in this research will last for at least 12 months and up to 24 months if you are among the first to enroll in the study.

Inclusion/Exclusion Criteria

  1. Inclusion
    1. Male or female, aged 30 years or greater
    2. MRC ≥ 2 or CAT ≥ 10
    3. Former smokers or current smokers and never-smokers are eligible for study inclusion
      1. Current smokers must refrain from smoking when using supplemental oxygen or the myAirvo-3 device
    4. History of a severe COPD exacerbation requiring hospitalization in the previous six weeks
    5. FEV1/FVC of < 70% and an FEV1 of < 80% (GOLD stages II – IV, Grade E)
      1. 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.
    6. COPD in a stable condition after hospitalization in accordance to study criteria
    7. 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
    8. Willing to record symptoms, pulse oximetry, and heart rate on a daily basis
    9. Have a home environment suitable for myAirvo 3 use
    10. Agreement to adhere to Lifestyle Considerations study duration –refraining from smoking while receiving supplemental oxygen or the myAirvo-3 device
  2. Exclusion
    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

 

 

Open Enrollment

Contact Name: Ashley Carter
Contact Phone: (904) 244-9962
Contact Email: ashley.carter@jax.ufl.edu

Investigators