- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05938738
PEP-buddy in COPD: Effect on Dyspnea Severity and Mechanism of Action (RELIEF)
June 30, 2023 updated by: JE Hartman, University Medical Center Groningen
A Portable Dyspnea Relief Device for Episodic Breathlessness in COPD (PEP-buddy): Effect on Dyspnea Severity and Mechanism of Action
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 Overview
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jorine Hartman, PhD
- Phone Number: +31503616161
- Email: j.hartman@umcg.nl
Study Contact Backup
- Name: Marlies van Dijk, MD PhD
- Phone Number: +31503616161
- Email: m.van.dijk05@umcg.nl
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PEP-buddy
Patients will use the PEP-buddy as needed.
|
PEP-buddy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2024
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
June 22, 2023
First Submitted That Met QC Criteria
June 30, 2023
First Posted (Actual)
July 10, 2023
Study Record Updates
Last Update Posted (Actual)
July 10, 2023
Last Update Submitted That Met QC Criteria
June 30, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RELIEF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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