A Portable Dyspnea Relief Device for Episodic Breathlessness in COPD (PEP-buddy): Effect on Dyspnea Severity and Mechanism of Action
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Dyspnea severity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
PEP-buddy
Patients will use the PEP-buddy as needed.
Intervention: PEP-buddy (Device)
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
JE Hartman
Principal investigator
University Medical Center Groningen