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

Not Applicable

Recruiting

• Conditions: COPD
• Interventions: Device: PEP-buddy

• Registration Number: NCT05938738
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-10
• Study Start: 2024-01-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Age ≥40 years

2. Read, understood and signed Informed Consent

3. COPD Gold class II-IV/ B or E (FEV1<60% of predicted, CAT ≥10 points)

4. Optimized standard therapy according to the study physician 6. Episodic breathlessness requiring intervention (i.e. taking rest during physical activities, as needed inhalation medication, breathing techniques, as needed opioids) at least three days per week

Exclusion Criteria

1. Other severe disease causing episodic breathlessness
2. Life expectancy ≤ 3 months
3. Exacerbation of COPD 4 weeks prior to inclusion
4. Change in COPD management targeted at breathlessness 8 weeks prior to inclusion
5. Inability to use the PEP buddy device
6. Currently participating in another interventional clinical study
7. Any other conditions, which, in the opinion of the investigator would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEP-buddy	PEP-buddy	Patients will use the PEP-buddy as needed.

Primary Outcome Measures

Name	Time	Method
Dyspnea severity	4 weeks	To investigate the effect of the portable dyspnea relief device on dyspnea severity after 4 weeks. Dyspnea severity is measured by the dyspnea domain of the chronic respiratory questionnaire (CRQ), this score of this scale ranges from 5-35, with a higher score indicating more severe dyspnea.

Trial Locations

Locations (1)

UMCG; 🇳🇱 Groningen, Netherlands