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Action Plan to enhance self-management and early detection of exacerbations in patients with COPD; a Randomized Controlled Trial

Completed
Conditions
Chronic Bronchitis
Chronic lung disease
COPD
Emphysema
10006436
Registration Number
NL-OMON32089
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
180
Inclusion Criteria

- Diagnosis of COPD based on post-bronchodilatator FEV1 according to the GOLD
standards (=NHG standard).
- Diagnosis of COPD as the major functionally limiting disease.
- Current use of bronchodilator therapy.

Exclusion Criteria

- Primary diagnosis of asthma (onset < 35 years, >= 12 % postbronchodilator
reversibility in FEV1)
- Primary diagnosis of cardiac disease
- Primary diagnosis of other functionally limiting disease, that could significantly
affect either patient mortality (e.g. malignant neoplasm) or participation in the
study (e.g. confusional states, psychoses)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>- (Clinical COPD Questionnaire) CCQ Symptom recovery time in the event of an<br /><br>exacerbation; number of 3 day CCQ units<br /><br>for the CCQ symptom score to have recovered from the exacerbation onset to<br /><br>the pre-exacerbation 3 unit average. </p><br>
Secondary Outcome Measures
NameTimeMethod
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