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

Primary Purpose

COPD

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PEP-buddy
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PEP-buddy

    Arm Description

    Patients will use the PEP-buddy as needed.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 22, 2023
    Last Updated
    June 30, 2023
    Sponsor
    University Medical Center Groningen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05938738
    Brief Title
    PEP-buddy in COPD: Effect on Dyspnea Severity and Mechanism of Action
    Acronym
    RELIEF
    Official Title
    A Portable Dyspnea Relief Device for Episodic Breathlessness in COPD (PEP-buddy): Effect on Dyspnea Severity and Mechanism of Action
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Medical Center Groningen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COPD

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PEP-buddy
    Arm Type
    Experimental
    Arm Description
    Patients will use the PEP-buddy as needed.
    Intervention Type
    Device
    Intervention Name(s)
    PEP-buddy
    Intervention Description
    PEP-buddy
    Primary Outcome Measure Information:
    Title
    Dyspnea severity
    Description
    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.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jorine Hartman, PhD
    Phone
    +31503616161
    Email
    j.hartman@umcg.nl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marlies van Dijk, MD PhD
    Phone
    +31503616161
    Email
    m.van.dijk05@umcg.nl

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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