Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT05938738

PEP-buddy in COPD: Effect on Dyspnea Severity and Mechanism of Action

Led by University Medical Center Groningen · Updated on 2026-04-24

25

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic dyspnea is the most characteristic symptom of patients with Chronic Obstructive Pulmonary Disease (COPD), with intermittent increases during exercise and other events.Despite optimal standard therapy, episodic dyspnea is a common occurrence in COPD. Recently, the PEP buddy was developed which is an easy-to use, hands-free device that generates positive expiratory pressure (PEP). Although currently the available evidence is limited, it indicates that utilizing the PEP-buddy can result in enhancements in dyspnea during exertion, exertional desaturation and overall quality of life. More research is needed to evaluate the effectiveness of this device and the long term usability, as well as getting more insight in the mechanism of action. Therefore, the aim of our study is to explore the potential of this device for patients with COPD and episodic breathlessness.

CONDITIONS

Official Title

PEP-buddy in COPD: Effect on Dyspnea Severity and Mechanism of Action

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 40 years or older
  • Read, understood and signed Informed Consent
  • COPD Gold class II-IV/ B or E (FEV1 less than 60% of predicted, CAT 10 points or higher)
  • Optimized standard therapy according to the study physician
  • Episodic breathlessness requiring intervention at least three days per week
Not Eligible

You will not qualify if you...

  • Other severe disease causing episodic breathlessness
  • Life expectancy 3 months or less
  • COPD exacerbation within 4 weeks prior to inclusion
  • Change in COPD management targeting breathlessness within 8 weeks prior to inclusion
  • Inability to use the PEP buddy device
  • Currently participating in another interventional clinical study
  • Any other condition that the investigator believes makes the patient unsuitable or interferes with study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UMCG

Groningen, Provincie Groningen, Netherlands, 9700 RB

Actively Recruiting

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Research Team

J

Jorine Hartman, PhD

CONTACT

M

Marlies van Dijk, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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