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

NCT ID: NCT05938738

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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PEP-buddy

Patients will use the PEP-buddy as needed.

Group Type EXPERIMENTAL

PEP-buddy

Intervention Type DEVICE

PEP-buddy

Interventions

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PEP-buddy

PEP-buddy

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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JE Hartman

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UMCG

Groningen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Jorine Hartman, PhD

Role: CONTACT

+31503616161

Marlies van Dijk, MD PhD

Role: CONTACT

+31503616161

Facility Contacts

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Jorine Hartman, PhD

Role: primary

Else ter Haar, MD

Role: backup

Other Identifiers

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RELIEF

Identifier Type: -

Identifier Source: org_study_id

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