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

Sponsor
University Medical Center Groningen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05938738
Collaborator
(none)
25
Enrollment
1
Arm
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PEP-buddy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Portable Dyspnea Relief Device for Episodic Breathlessness in COPD (PEP-buddy): Effect on Dyspnea Severity and Mechanism of Action
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: PEP-buddy

Patients will use the PEP-buddy as needed.

Device: PEP-buddy
PEP-buddy

Outcome Measures

Primary Outcome Measures

  1. Dyspnea severity [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

  4. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Medical Center Groningen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
JE Hartman, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier:
NCT05938738
Other Study ID Numbers:
  • RELIEF
First Posted:
Jul 10, 2023
Last Update Posted:
Jul 10, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dyspnea

Study Results

No Results Posted as of Jul 10, 2023