PEP Buddy in COPD Pulmonary Rehabilitation
Official title: A Randomized, Sham Controlled Clinical Trial to Assess the Effectiveness of a Positive End Expiratory Device for Accelerating and Maintaining Pulmonary Rehabilitation Gains
Run by VA Office of Research and Development · NCT07404826 · Data updated 2026-11-12
This trial tests whether a breathing-assist device (PEP Buddy) helps veterans with COPD improve symptoms and exercise capacity during and after pulmonary rehabilitation more quickly than a sham device.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 89 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (Cincinnati, Ohio and 1 other locations) |
| Status | Recruiting |
| Started | July 16, 2026 |
| Main results expected | July 29, 2030 |
| Study ends | July 29, 2030 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT07404826 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Veterans with COPD referred to pulmonary rehabilitation, FEV1 less than 80% predicted, able to exercise while on 4 L/min nasal cannula O2.
✕Probably not a fit
Patients whose COPD symptoms are not responsive to breathing-assist therapy or who have non-COPD conditions driving dyspnea may not see benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind, sham-controlled study compares a breathing-support device (PEP Buddy) to a sham device in veterans with COPD undergoing pulmonary rehabilitation. Participants are assigned to intervention or sham and followed through pulmonary rehabilitation and up to one year after discharge. Outcomes include changes in quality of life and functional capacity over time. The trial aims to determine if the PEP Buddy provides additional or longer-lasting benefits beyond standard rehabilitation. The study is conducted at two VA medical centers in Ohio with Veterans eligible based on COPD-related criteria.
Why it matters
Potential benefit: If successful, participants using the PEP Buddy may experience faster and longer-lasting improvements in symptoms and exercise ability during and after pulmonary rehabilitation.
How similar studies have gone: Prior research with breathing-support devices in COPD has shown mixed results; this study adds rigor with randomization and sham control to clarify effectiveness.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veteran * Referral to Pulmonary Rehabilitation for COPD * FEV1 \<80% predicted * Participants must be able to exercise on 4L/m nasal cannula O2 Exclusion Criteria: * Those deemed by the study personnel to have a lung disease other than COPD impacting their daily dyspnea * Those that are unable to perform study procedures or are unwilling or unable to use PEP Buddy * Those that have a component of lung disease driven by aspiration or neurological conditions affecting the face or oropharynx * Those with a life expectancy of \<1 year * Those with a known surgical intervention that will require a prolonged recovery in the year after enrollment * Those with a malignancy beyond Stage I or non-melanoma skin cancer * Those shown shown to have memory loss of MOCA testing
Where it's running
-
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, United States Recruiting -
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States Not yet recruiting
Study contacts
- Principal investigator: Robert Matthew Burkes, MD MS — Cincinnati VA Medical Center, Cincinnati, OH
- Study coordinator: Robert M Burkes, MD MS
- Email: robert.burkes@va.gov
- Phone: (724) 730-3862
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.