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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

642 Participants
are divided into 2 treatment groups
Group A: Usual COPD careActive comparator 1 intervention
Group B: Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 to first moderate or severe COPD exacerbation

Time frame
1 year

Secondary outcomes

1

Time to first severe exacerbation

To determine if HFNT delivered by myAirvo 3 increases the time to first severe exacerbation

Time frame
1 year
2

Time to moderate or severe exacerbation

To determine if HFNT delivered by myAirvo 3 increases the time to first exacerbation (moderate or severe)

Time frame
1 year
3

Severe exacerbation frequency

To determine if HFNT delivered by myAirvo 3 reduces severe exacerbation frequency

Time frame
1 year
4

Moderate/severe exacerbation frequency

To determine if HFNT delivered by myAirvo reduces moderate and severe exacerbation frequency

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Temple University

Lead sponsor

Fisher and Paykel Healthcare

Collaborator

Source ClinicalTrials.gov
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