A portable dyspnea RELIEF device for episodic breathlessness in COPD (PEP-buddy): effect on dyspnea severity and mechanism of actio
- Conditions
- COPD10038716
- Registration Number
- NL-OMON55983
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
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) 4. Optimized
standard therapy according to the study physician 5. 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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate the effect of the portable dyspnea relief device on dyspnea<br /><br>severity measured by the CRQ questionnaire after 4 weeks of the use of the<br /><br>PEP-buddy.</p><br>
- Secondary Outcome Measures
Name Time Method