NCT05938738Recruiting
PEP-buddy in COPD: Effect on Dyspnea Severity and Mechanism of Action
A Portable Dyspnea Relief Device for Episodic Breathlessness in COPD (PEP-buddy): Effect on Dyspnea Severity and Mechanism of Action
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 22 Jun 2023
- Start date
- Jan 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- University Medical Center Groningen
- Diseases
- COPD
- NCT number
- NCT05938738
What you commit to
- Study type: Interventional
- Planned participants: 25
- From Jan 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Exacerbation of COPD 4 weeks prior to inclusion
- Change in COPD management targeted at breathlessness 8 weeks prior to inclusion
Other illness
- Other severe disease causing episodic breathlessness
- 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.
Other
- Life expectancy ≤ 3 months
- Inability to use the PEP buddy device
- Currently participating in another interventional clinical study
Who the study is looking for
- Age ≥40 years
- Read, understood and signed Informed Consent
- COPD Gold class II-IV/ B or E (FEV1\<60% of predicted, CAT ≥10 points)
- 5\. 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UMCG Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.