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Device

High Flow Nasal Therapy for COPD

N/A
Recruiting
Research Sponsored by Temple University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
MRC score ≥ 2 or CAT score ≥ 10
Male or female, aged 30 years or greater
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether home High flow Nasal Therapy (HFNT) is better than usual COPD medical care for exacerbation prevention in moderate to very severe COPD patients.

Who is the study for?
This trial is for COPD patients aged 40+, who've had a severe exacerbation requiring hospitalization in the past 6 weeks. They must be able to use myAirvo 3 at home, record daily symptoms, and commit to the study's duration. Smokers with a ≥10 pack-year history can join if they meet specific lung function criteria (GOLD stages II-IV). Exclusions include certain sleep apnea scores, recent investigational drug use, life expectancy under 12 months due to other conditions, oxygen needs over 15 L/min, or inability to tolerate nasal prongs.Check my eligibility
What is being tested?
The trial tests if High Flow Nasal Therapy (HFNT) using myAirvo 3 plus usual medical care improves outcomes for COPD patients compared to usual care alone. It's a phase III study where participants are randomly assigned into two groups: one receiving HFNT at home and the other not. The treatment lasts between one and two years.See study design
What are the potential side effects?
While specific side effects of HFNT via myAirvo3 aren't detailed here, potential issues might include discomfort from nasal prongs or dryness/irritation of airways due to high-flow therapy. Usual COPD treatments may continue alongside which have their own range of possible side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breathing difficulty is moderate to severe.
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I am 30 years old or older.
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My COPD is stable since my last hospital visit.
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My lung function is significantly reduced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
Adverse event reporting
Correlations with average hours of use
Cost effectiveness
+11 more

Trial Design

2Treatment groups
Active Control
Group I: Usual COPD careActive Control1 Intervention
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
Group II: Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator.Active Control1 Intervention
The intervention is the myAirvo 3 humidifier with integrated flow generator delivered through the Optiflow™ + Duet nasal cannula.

Find a Location

Who is running the clinical trial?

Fisher and Paykel HealthcareIndustry Sponsor
120 Previous Clinical Trials
9,306 Total Patients Enrolled
Temple UniversityLead Sponsor
297 Previous Clinical Trials
82,331 Total Patients Enrolled
Fisher & Paykel HealthcareUNKNOWN

Media Library

myAirvo3 (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05204888 — N/A
Chronic Obstructive Pulmonary Disease Research Study Groups: Usual COPD care, Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator.
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: myAirvo3 Highlights & Side Effects. Trial Name: NCT05204888 — N/A
myAirvo3 (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05204888 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity for enrollees in this clinical trial?

"Indeed, current records on clinicaltrials.gov reveal that this research is still open to candidates. As of February 2nd 2022, the trial initially commenced and was last updated 21 days later. 642 individuals are necessary for participation at a single research facility."

Answered by AI

Can individuals still submit their applications for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this study has been posted since February 2nd 2022 and recently updated on the 21st of the same month. 642 individuals have to be recruited from a single medical centre for participation in this trial."

Answered by AI

Who else is applying?

What site did they apply to?
University of Minnesota
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
2022. "myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05204888.
~354 spots leftby Jan 2027
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