Using a device to help manage breathlessness in COPD patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Umcg
  Groningen, Provincie Groningen, Netherlands Recruiting

Study contacts

• Study coordinator: Jorine Hartman, PhD
• Email: j.hartman@umcg.nl
• Phone: +31503616161

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.