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

COPD Clinical Trial

— RELIEF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938738
• Other study ID #: RELIEF
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: Jorine Hartman, PhD
• Phone: +31503616161
• Email: j.hartman[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Age =40 years

2. Read, understood and signed Informed Consent

3. 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:

1. Other severe disease causing episodic breathlessness

2. Life expectancy = 3 months

3. Exacerbation of COPD 4 weeks prior to inclusion

4. Change in COPD management targeted at breathlessness 8 weeks prior to inclusion

5. Inability to use the PEP buddy device

6. Currently participating in another interventional clinical study

7. 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.

Related Conditions & MeSH terms

• COPD
• Dyspnea

Intervention

Device:
• PEP-buddy
PEP-buddy

Locations

Country	Name	City	State
Netherlands	UMCG	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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