Respiratory microbiome and clinical data analysis for the prediction of acute exacerbations in COPD
Recruiting
- Conditions
- COPD
- Registration Number
- NL-OMON26474
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
•Age = 18 years
•Written informed consent
•Physician-confirmed diagnosis of COPD (spirometry) (FEV1= 80% predicted)
•Smoking history: Min. 10 packyears
Exclusion Criteria
•Inability to understand the nature, scope, and possible consequences of the study
•Life expectancy of less than 12 months
•Newly diagnosed active pulmonary tuberculosis within the last 12 months • Unstable cardiopulmonary or metabolic co-morbidities
•Macrolide maintenance treatment
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accuracy of risk assessment for the prediction of acute exacerbations of COPD based on microbiological and clinical analyses.
- Secondary Outcome Measures
Name Time Method •Composition of the respiratory microbiota in patients with COPD and relation to exacerbation history and clinical parameters <br>•Compositional clustering of respiratory microbiota in relation to disease phenotype <br>•Stability of the respiratory microbiota in patients with COPD in the stable phase, during exacerbation and recovery <br>•Host gene signatures in relation to respiratory microbiota profile