COPDPEPRNCT07404826
PEP Buddy in Pulmonary Rehabilitation
A study testing PEP Buddy in people with COPD, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
In this study, the investigators will test Veterans with COPD in Pulmonary Rehabilitation. Between two groups, the investigators will give one group a device that assists with breathing and symptoms and the other receives a 'sham' device which does not provide these benefits. Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- COPD
- What is being tested?
- PEP Buddy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jul 2026to 29 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran
- Referral to Pulmonary Rehabilitation for COPD
- FEV1 <80% predicted
- Participants must be able to exercise on 4L/m nasal cannula O2
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220-2213
Robert M Burkes, MD MS, (724) 730-3862, robert.burkes@va.gov
Robert Matthew Burkes, MD MS
- Not yet recruiting
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
Frank Jacono, MD, 216-791-3800 ext. 65628, frank.jacono@va.gov
Anthony Vergis, MD, 2167913800 ext. 65628, anthony.vergis@va.gov
About this study
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
In this study, the investigators will test Veterans with COPD in Pulmonary Rehabilitation. Between two groups, the investigators will give one group a device that assists with breathing and symptoms and the other receives a 'sham' device which does not provide these benefits. The investigators will test to see if the symptoms and exercise capacity of the group who receives this device improves faster in Pulmonary Rehabilitation and has longer lasting benefits after the end of Pulmonary Rehabilitation.
Read the detailed description
In this randomized, double-blinded, sham-controlled clinical trial, the investigators will test the effectiveness of the use of a positive expiratory device (PEP Buddy) vs. sham in participants with COPD in Pulmonary Rehabilitation and after discharge from Pulmonary Rehabilitation for up to one year. The investigators will compare changes in quality of life metrics and measurements of functional capacity between the intervention and sham groups over the course of the study.
- Conditions
- COPD
- Being tested
- PEP Buddy, PEP Buddy Sham
- Keywords
- Pulmonary Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP BuddyDevice
This is a small, portable device worn about the neck with a lanyard, that can be used to control symptoms of breathlessness associated with chronic lung disease.
PEP Buddy ShamDevice
Also called Sham
A Device that appears the same as PEP Buddy but only provides the expiratory pressure of the standard-of-care pursed lip breathing
| Study group | Role | What they receive |
|---|---|---|
| PEP Buddy | Experimental | This arm will be provided with a portable device that provides 5-7 cm H2O of expiratory pressure, to be used when subjectively breathless Receives: Device: PEP Buddy |
| Sham | Sham comparator | This arm will be provided with a portable device that appears the same as PEP Buddy but provides 1-3 cm H2O of expiratory pressure, to be used when subjectively breathless Receives: Device: PEP Buddy Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
San Diego Shortness of breath Questionnaire
This is a standardized survey used to quantify the impact of daily respiratory symptoms on quality of life. This will be collected on enrollment and the investigators will compare the change between groups at Weeks 3, 6, 9, and 12 and at six-and twelve-months after enrollment.
Measured: 12 Months
Daily steps measured by wrist-wron accelerometer
Using accelerometry, the investigators will show the changes in daily step counts between groups over the one year of time in the study.
Measured: 12 Months
Secondary outcomes (3)
One-Minute Sit to Stand test
The investigators will perform this test at enrollment and at weeks 3, 6, 9, and 12 as well as six-and twelve-months after enrollment and compare between groups. This test calculates the number of times a participant can sit and rise from a chair over the course of a minute.
Measured: 12 Months
Six Minute Walk Test
A standard test of exercise capacity in those with chronic lung disease. The investigators will assess changes in the six-minute walk test difference from enrollment at Weeks 3, 6, 9, and 12 in the study and at six-and twelve-months after the conclusion of the study.
Measured: 12 months
St. George Respiratory Questionaire
The investigators will compare the values between groups from enrollment at Weeks 3, 6, 9, and 12 and at six-and twelve-months after enrollment. This is a standard survey form in which participants report the severity and daily impact of respiratory symptoms and how they may inhibit daily activity.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start16 Jul 2026
- Primary completion29 Jul 2030 (estimated)
- Study completion29 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be block randomized in groups of varying sizes to either PEP Buddy or sham. The PEP Buddy and sham groups will run in parallel.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Robert Matthew Burkes, MD MS, Principal investigator, Cincinnati VA Medical Center, Cincinnati, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404826
- Sponsor's protocol ID
- RRD6-010-24W
- Other IDs
- 1I01RD000440-01A2, 25-81
- Acronym
- PEPR
- Status last verified
- Jul 2026
- First submitted
- 4 Feb 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The investigators will share data with VA researchers that will be de-identified via Safe Harbor approach. However, if a non-VA researcher requests aggregate data, the investigators will work with local research office, facility privacy officer, and information security officer to identify an applicable agreement for data sharing. No VA data will include any PHI to any non-VA researchers requesting VA data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07404826
- Acronym / sponsor ID
- PEPR / RRD6-010-24W
- Conditions
- COPD
- Keywords
- Pulmonary Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 29 Jul 2030 (estimated)
- Study completion
- 29 Jul 2030 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators will test Veterans with COPD in Pulmonary Rehabilitation. Between two groups, the investigators will give one group a device that assists with breathing and symptoms and the other receives a 'sham' device which does not provide these benefits. The investigators will test to see if the symptoms and exercise capacity of the group who receives this device improves faster in Pulmonary Rehabilitation and has longer lasting benefits after the end of Pulmonary Rehabilitation.
Detailed description
In this randomized, double-blinded, sham-controlled clinical trial, the investigators will test the effectiveness of the use of a positive expiratory device (PEP Buddy) vs. sham in participants with COPD in Pulmonary Rehabilitation and after discharge from Pulmonary Rehabilitation for up to one year. The investigators will compare changes in quality of life metrics and measurements of functional capacity between the intervention and sham groups over the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be block randomized in groups of varying sizes to either PEP Buddy or sham. The PEP Buddy and sham groups will run in parallel.
| Arm | Type | Receives |
|---|---|---|
| PEP Buddy | Experimental | Device: PEP BuddyThis arm will be provided with a portable device that provides 5-7 cm H2O of expiratory pressure, to be used when subjectively breathless |
| Sham | Sham comparator | Device: PEP Buddy ShamThis arm will be provided with a portable device that appears the same as PEP Buddy but provides 1-3 cm H2O of expiratory pressure, to be used when subjectively breathless |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veteran
- Referral to Pulmonary Rehabilitation for COPD
- FEV1 <80% predicted
- Participants must be able to exercise on 4L/m nasal cannula O2
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP BuddyThis is a small, portable device worn about the neck with a lanyard, that can be used to control symptoms of breathlessness associated with chronic lung disease. | Device | PEP Buddy |
| PEP Buddy ShamAlso: ShamA Device that appears the same as PEP Buddy but only provides the expiratory pressure of the standard-of-care pursed lip breathing | Device | Sham |
Primary outcome
San Diego Shortness of breath Questionnaire
Time frame: 12 Months
This is a standardized survey used to quantify the impact of daily respiratory symptoms on quality of life. This will be collected on enrollment and the investigators will compare the change between groups at Weeks 3, 6, 9, and 12 and at six-and twelve-months after enrollment.
Daily steps measured by wrist-wron accelerometer
Time frame: 12 Months
Using accelerometry, the investigators will show the changes in daily step counts between groups over the one year of time in the study.
3 secondary outcomes
One-Minute Sit to Stand test
Time frame: 12 Months
Six Minute Walk Test
Time frame: 12 months
St. George Respiratory Questionaire
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Yes. The investigators will share data with VA researchers that will be de-identified via Safe Harbor approach. However, if a non-VA researcher requests aggregate data, the investigators will work with local research office, facility privacy officer, and information security officer to identify an applicable agreement for data sharing. No VA data will include any PHI to any non-VA researchers requesting VA data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Matthew Burkes, MD MS principal investigator
Cincinnati VA Medical Center, Cincinnati, OH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEP Buddy in people with COPD, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert M Burkes, MD MS ((724) 730-3862, robert.burkes@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
San Diego Shortness of breath Questionnaire (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.