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

Conditions

• COPD

Eligibility Criteria

Sex

ALL

Age

30 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• myAirvo3 — DEVICE
  For patients assigned to the HFNT intervention group, a myAirvo 3 device will be provided. The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 - 60 L/min depending on the patient interface. The myAirvo 3 is for patients in homes and long-term care facilities.
• Pulse oximeter — DEVICE
  A pulse oximeter will be provided to measure heart rate and pulse oximetry; subjects will enter and transmit the data on the smartphone once daily before 11AM. Heart rate and pulse oximetry measures will be taken after wearing the device for approximately 2 minutes.

Study Details

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.

Key Dates

Start date

Feb 2, 2022

Status verified

Jan 2025

Primary completion

Jan 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

642 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Usual COPD care
  The intervention : A pulse oximeter to record heart rate and pulse oximetry on a daily basis will be provided. A smart phone and charger will also be provided to answer a short questionnaire that queries daily respiratory symptoms plus enter heart rate and pulse oximetry data
• Active Comparator: Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator.
  The intervention is the myAirvo 3 humidifier with integrated flow generator delivered through the Optiflow™ + Duet nasal cannula.

Primary Outcome Measure

To determine if myAirvo 3 use increases the time to first moderate exacerbation/severe exacerbation (hospitalization)/all-cause mortality in patients with moderate to very severe COPD. [ Time Frame: 1 year ]

Central Contacts

• Gerard Criner, MD
  215-707-8113
  [email protected]
• Stephanie Yerkes
  215-707-2357
  [email protected]

Locations (25)

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