RecruitingNot ApplicableNCT05938738

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

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

Sponsor

University Medical Center Groningen

Enrollment

25 participants

Start Date

Jan 31, 2024

Study Type

INTERVENTIONAL

Conditions

COPD

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

Min Age: 40 Years

Inclusion Criteria4

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 Criteria7

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.