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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

Must not have

Recent upper airway surgery (within the previous month)

Life expectancy less than 12 months due to COPD or other comorbid condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my upper airway in the last month.

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My doctor expects I have less than 12 months to live due to my COPD or another health condition.

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I cannot tolerate nasal prongs.

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I use a CPAP or similar device regularly for my sleep.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Adverse event reporting

Correlations with average hours of use

Cost effectiveness

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met