PEP Buddy for COPD

(PEPR Trial)

Not yet recruiting at 1 trial location
RM
Overseen ByRobert M Burkes, MD MS
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device called PEP Buddy to assist veterans with COPD (a lung disease that makes breathing difficult) during Pulmonary Rehabilitation. The study compares two groups: one uses the PEP Buddy, which aids breathing, and the other uses a look-alike device without the same benefits. Researchers aim to determine if the PEP Buddy group experiences faster improvements and longer-lasting benefits. Veterans with COPD who are already referred for Pulmonary Rehabilitation and can exercise with supplemental oxygen might be suitable candidates. As a Phase 2, Phase 3 trial, this study focuses on evaluating the effectiveness of the PEP Buddy and represents the final step before FDA approval, offering veterans a chance to contribute to important research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the PEP Buddy device is safe for use in COPD patients?

Research has shown that the PEP Buddy device, which adds pressure when exhaling to aid breathing, is generally safe for people with COPD, a condition that makes breathing difficult. One study found that the device improved breathing in about 72% of participants, indicating effectiveness without major issues. Another study noted that devices like PEP Buddy, which use positive pressure during exhalation, are often used to assist with breathing and are well-tolerated.

While information on side effects is limited, available research does not report any significant negative effects, suggesting that the PEP Buddy is likely safe for people with COPD. However, as this study is in the late stages of clinical trials, any rare side effects might still be under investigation. Overall, the PEP Buddy appears promising as a safe option for easing breathing difficulties in COPD.12345

Why do researchers think this study treatment might be promising for COPD?

The PEP Buddy is unique because it offers a new way to manage breathlessness in people with COPD by providing a portable device that delivers 5-7 cm H2O of expiratory pressure. Unlike current treatments like bronchodilators and corticosteroids, which focus on reducing inflammation and opening airways, the PEP Buddy aims to improve breathing efficiency through positive expiratory pressure. Researchers are excited about this device because it could offer immediate relief during episodes of breathlessness, providing a simple and non-invasive alternative to standard medications.

What evidence suggests that the PEP Buddy device is effective for COPD?

Research shows that the PEP Buddy device can greatly assist people with COPD (chronic obstructive pulmonary disease). Studies have found that over 70% of users experienced less shortness of breath after using the device. Participants in this trial will be assigned to one of two arms: one receiving the PEP Buddy device, which provides 5-7 cm H2O of expiratory pressure, and a sham comparator arm with a device that appears the same but provides only 1-3 cm H2O of expiratory pressure. Previous studies have shown that users of the PEP Buddy device improved their exercise ability and overall quality of life, suggesting it could be a useful tool for managing COPD symptoms.12367

Who Is on the Research Team?

RM

Robert Matthew Burkes, MD MS

Principal Investigator

Cincinnati VA Medical Center, Cincinnati, OH

Are You a Good Fit for This Trial?

This trial is for Veterans with COPD who have less than 80% of the predicted lung function and are referred to Pulmonary Rehabilitation. They must be able to exercise while using supplemental oxygen. People with significant memory loss, other major lung diseases, short life expectancy, upcoming major surgeries, or advanced cancer can't join.

Inclusion Criteria

FEV1 <80% predicted
Veteran
I have been referred to a lung rehab program for my COPD.
See 1 more

Exclusion Criteria

Those shown shown to have memory loss of MOCA testing
My lung condition is caused by swallowing problems or nerve issues affecting my face or throat.
Those with a life expectancy of <1 year
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pulmonary Rehabilitation

Participants undergo pulmonary rehabilitation with either the PEP Buddy device or a sham device

12 weeks
Visits at Weeks 3, 6, 9, and 12

Follow-up

Participants are monitored for changes in quality of life and functional capacity after pulmonary rehabilitation

12 months
Assessments at six and twelve months

What Are the Treatments Tested in This Trial?

Interventions

  • PEP Buddy

Trial Overview

The study compares two groups: one uses a PEP Buddy device designed to help with breathing and symptoms during Pulmonary Rehabilitation; the other group gets a sham device that doesn't provide these benefits. The goal is to see if the PEP Buddy group improves more in terms of symptoms and exercise capacity.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: PEP BuddyExperimental Treatment1 Intervention
Group II: ShamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

Impact of positive expiratory pressure buddy during exercise ...

Efficacy and safety of long-term use of a positive expiratory pressure device in chronic obstructive pulmonary disease patients, a randomized controlled trial.

PEP Buddy Impact on Breathing, Exercise, and Sleep ...

A positive expiratory pressure device improved COPD-related symptoms in more than 70% of patients with COPD. PEP buddy is an adjunct to current COPD therapies, ...

A Hands-Free, Oral Positive Expiratory Pressure Device for ...

In this proof-of-efficacy study, PEP Buddy generating 4–10 cm H2O of expiratory pressure improved exertional dyspnea in 71.8% of participants with moderate-to- ...

Small Device Improves Breathlessness in Patients With ...

The study found that 23 (72%) participants had improved shortness of breath (FEV 1, 40.4% vs 56.5%; P = .009) and forced vital capacity (68.5% ...

Breathing Device Could Aid Patients with Chronic ...

Results showed that 72% of participants experienced a significant reduction in shortness of breath and improvement in quality of life.

PEP-buddy in COPD: Effect on Dyspnea Severity and ...

Although currently the available evidence is limited, it indicates that utilizing the PEP-buddy can result in enhancements in dyspnea during ...

A hands-free, oral positive expiratory pressure device

This review examines the PEP Buddy's design, mechanisms, clinical evidence, role in pulmonary rehabilitation, limitations, and future research ...