UMCG
Groningen, Provincie Groningen, 9700 RB, Netherlands
Location status: Recruiting
Recruiting
NCT Number: NCT05938738
PEP-buddy in COPD: Effect on Dyspnea Severity and Mechanism of Action
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
40 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age ≥40 years
- Read, understood and signed Informed Consent
- COPD Gold class II-IV/ B or E (FEV1<60% of predicted, CAT ≥10 points)
- 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
- Other severe disease causing episodic breathlessness
- Life expectancy ≤ 3 months
- Exacerbation of COPD 4 weeks prior to inclusion
- Change in COPD management targeted at breathlessness 8 weeks prior to inclusion
- Inability to use the PEP buddy device
- Currently participating in another interventional clinical study
- 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.
Treatment and study plan
PEP-buddy
DevicePEP-buddy
Primary outcomes
-
Dyspnea severity
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Jorine Hartman, PhD
CONTACT
Marlies van Dijk, MD PhD
CONTACT
Sponsors and collaborators
Lead sponsor
University Medical Center Groningen
Other
Registry information
Official study title
A Portable Dyspnea Relief Device for Episodic Breathlessness in COPD (PEP-buddy): Effect on Dyspnea Severity and Mechanism of Action
Acronym: RELIEF
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 10, 2023
- Registry last updated
- Apr 24, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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