PEP-buddy in COPD: Effect on Dyspnea Severity and Mechanism of Action
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PEP-buddy.
- Who it may be relevant to
- Registry conditions: COPD. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Portable Dyspnea Relief Device for Episodic Breathlessness in COPD (PEP-buddy): Effect on Dyspnea Severity and Mechanism of Action
Overview
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.
Interventions
- Device PEP-buddy
PEP-buddy
Primary outcome measures
- Dyspnea severity [Time frame: 4 weeks]
Eligibility criteria
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)
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Netherlands · 1 center
- UMCG — Groningen
Identifiers
NCT: NCT05938738 · RELIEF