COPD
Conditions
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.
Interventions
DEVICEPEP-buddy
PEP-buddy
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea severity | 4 weeks | 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. |
Countries
Netherlands
Contacts
CONTACTJorine Hartman, PhD
CONTACTMarlies van Dijk, MD PhD
Outcome results
None listed