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

Study Overview
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Brief Summary
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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.

Official Title
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A Portable Dyspnea Relief Device for Episodic Breathlessness in COPD (PEP-buddy): Effect on Dyspnea Severity and Mechanism of Action

Conditions
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COPD

Intervention / Treatment
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* Device: PEP-buddy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEP-buddy<br>Patients will use the PEP-buddy as needed. | Device: PEP-buddy<br>* PEP-buddy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea severity | 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. | 4 weeks |