NCT05938738 PEP-buddy in COPD: Effect on Dyspnea Severity and Mechanism of Action
| NCT ID | NCT05938738 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-01-31 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2024-01-31 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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) 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05938738 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05938738 currently recruiting?
Yes, NCT05938738 is actively recruiting participants. Contact the research team at j.hartman@umcg.nl for enrollment information.
Where is the NCT05938738 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT05938738 clinical trial?
NCT05938738 is sponsored by University Medical Center Groningen. The trial plans to enroll 25 participants.
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