High flow nasal therapy for COPD patients at home

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of high flow nasal therapy (HFNT) using the myAirvo 3 device in conjunction with standard COPD medical care for patients with moderate to very severe COPD. It is a parallel-group, randomized, controlled trial involving 642 participants who have experienced severe exacerbations requiring hospitalization within the last six weeks. The study aims to determine if HFNT can prolong the time to first exacerbation or all-cause mortality, while also assessing its impact on hospitalization duration, quality of life, and safety. Participants will be monitored for up to two years to gather comprehensive data on the therapy's efficacy and safety.

Why it matters

Who can join: the full rules

To be eligible to participate in this study, an individual must meet all the following criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 30 years or greater
4. FEV1/FVC of \< 70% and an FEV1 of \< 80% (GOLD stages II - IV, Grade E)

   • Spirometry performed during the screening visit will be used to confirm GOLD stage. A prior spirometric test within the past 6 months can be substituted if available.
5. MRC ≥ 2 or CAT ≥ 10
6. Former smokers or current smokers and never-smokers are eligible for study inclusion

   • Current smokers must refrain from smoking when using supplemental oxygen or the myAirvo-3 device
7. History of a severe COPD exacerbation requiring hospitalization in the previous six weeks
8. COPD in a stable state after hospitalization defined as:

   * Clinically stable condition and have had no parenteral therapy for 24 hours.
   * Inhaled bronchodilators are required less than four-hourly.
   * Oxygen delivery has ceased for 24 hours (unless home oxygen is indicated).
   * If previously able, the patient is ambulating safely and independently, and performing activities of daily living.
   * The patient can eat and sleep without significant episodes of dyspnea.
   * The patient or caregiver understands and can administer medications.
   * Follow-up and home care arrangements (e.g., home oxygen, homecare, Meals on Wheels, community nurse, allied health, GP, specialist) have been completed.
9. Willing to adhere to the daily use of the myAirvo 3 regimen for at least 8 hours each day preferably at night following being shown and using the device
10. Willing to record daily symptoms and pulse oximetry and heart rate on daily basis
11. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

    Highly effective contraception is defined as:
    * A tubal ligation:
    * An approved hormonal contraceptive such as oral contraceptives, emergency contraception used as directed, patches, implants, injections, rings or intrauterine devices
12. Able to read and communicate in English
13. Have a home environment suitable for myAirvo 3 use.
14. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration - refraining from smoking while receiving supplemental oxygen or the myAirvo-3 device

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Current self-reported chronic use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV)
2. A STOPBang Questionnaire score \> 5\*
3. Pregnancy or lactation
4. Treatment with another investigational drug or other intervention within the previous 30 days
5. Life expectancy less than 12 months due to COPD or other comorbid condition.
6. Recent upper airway surgery (within the previous month)
7. Recent head or neck trauma (within the previous month)
8. Inability to tolerate nasal prongs
9. Requirement of oxygen greater than 15 L/min

   * subjects with a STOPBang questionnaire score of \> 5 may be eligible if a recent sleep study (within the previous 3 months) shows the absence of obstructive sleep apnea or the subject has, or is at risk of OSA, but refuses to use an OSA device and all other eligibility criteria are met.

Where it's running

• UAB School of Medicine/Lung Health Center
  Birmingham, Alabama, United States Recruiting
• Honor Health
  Scottsdale, Arizona, United States Recruiting
• University of Florida, Jacksonville
  Jacksonville, Florida, United States Recruiting
• Alloy Clinical Research
  Kissimmee, Florida, United States Recruiting
• Reliable Research, Inc.
  Miami, Florida, United States Recruiting
• NewGen Health Group
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Gerard Criner, MD
• Email: Gerard.Criner@tuhs.temple.edu
• Phone: 215-707-8113

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.