About HiFlo COPD Study
myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home – a Multi-Center Randomized Controlled Trial
myAirvo 3 is a High Flow Nasal Therapy (HFNT) being offered to COPD patients via a clinical trial. The myAirvo 3 device is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to the patient. Researchers are evaluating whether the device increases the time to when a patient experiences a COPD flareup, if it reduces flareup frequency, reduces hospitalization, improves quality of life, as well as other factors.
This is a 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 one year and up to two years in 642 GOLD Grade D, Stages III-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 six weeks.
Study Objective
To determine if HFNT delivered by myAirvo 3 increases the time to first moderate exacerbation or severe exacerbation or all-cause mortality in patients with moderate to very severe COPD
Secondary Objectives
To determine if HFNT delivered by myAirvo 3:
- Increases the time to first severe exacerbation
- Increases the time to first exacerbation (moderate or severe)
- Reduces severe exacerbation frequency
- Reduces moderate and severe exacerbation frequency
- Reduces hospitalization duration
- Improves quality of life
- Reduces dyspnea
- Reduces pCO2
- Is safe and well tolerated
- Determine if any of the objectives are related to duration of daily HFNT use
- Assess cost effectiveness of HFNT use
Study Participants
Included 642 patients with stable COPD (GOLD Stages III-IV, Grade D); males and females 40 years of age or older, who reside in the United States
Description of Intervention
Patients assigned to the HFNT group will be provided a myAirvo 3 device
- The myAirvo 3 is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.
- The interface used in this trial is the Optiflow™ + Duet nasal cannula sized for patient comfort.
- Patients will also be provided with a pulse oximetry device that connects to the myAirvo 3 to record pulse oximetry and heart rate once daily after wearing the device for two minutes.
Patients assigned to the control group will be provided with:
- A pulse oximetry device to record pulse oximetry and heart rate once daily after using the pulse oximeter for two minutes
- A respiratory questionnaire and will input data into a smartphone adapted to be used as an electronic diary.
