Using a device to help manage breathlessness in COPD patients
A Portable Dyspnea Relief Device for Episodic Breathlessness in COPD (PEP-buddy): Effect on Dyspnea Severity and Mechanism of Action
This study tests if a hands-free device can help people with COPD breathe easier during activities and improve their overall quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen, Provincie Groningen) |
| Trial ID | NCT05938738 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the PEP-buddy, a hands-free device that generates positive expiratory pressure, in reducing dyspnea severity in patients with Chronic Obstructive Pulmonary Disease (COPD). The research aims to explore how this device can improve episodic breathlessness during physical activities and enhance overall quality of life. Participants will be monitored for improvements in their symptoms and the long-term usability of the device will also be assessed. The study focuses on patients experiencing significant breathlessness despite optimized standard therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older with COPD classified as Gold class II-IV and experiencing episodic breathlessness at least three days a week.
Not a fit: Patients with other severe diseases causing breathlessness or those with a life expectancy of three months or less may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve the quality of life for COPD patients by reducing episodes of breathlessness.
How similar studies have performed: While evidence for the PEP-buddy's effectiveness is currently limited, similar approaches using positive expiratory pressure devices have shown promise in improving dyspnea in COPD patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Groningen, Provincie Groningen
- Umcg — Groningen, Provincie Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Jorine Hartman, PhD
- Email: j.hartman@umcg.nl
- Phone: +31503616161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.