NCT07404826

PEP Buddy in Pulmonary Rehabilitation

A Randomized, Sham Controlled Clinical Trial to Assess the Effectiveness of a Positive End Expiratory Device for Accelerating and Maintaining Pulmonary Rehabilitation Gains

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 40 Years – 89 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• COPD

Interventions

Type	Name	Description
DEVICE	PEP Buddy	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.
DEVICE	PEP Buddy Sham	A Device that appears the same as PEP Buddy but only provides the expiratory pressure of the standard-of-care pursed lip breathing

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-03-29
• Completion: 2030-03-29
• First posted: 2026-02-12
• Last updated: 2026-02-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study