Respiratory microbiome and clinical data analysis for the prediction of acute exacerbations in COPD

Conditions: chronic lung disease with persistent narrowing of the airways
Chronic Obstructive Pulmonary Disease (COPD)
10038716

Registration Number: NL-OMON51796

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 150

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 invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Accuracy of risk assessment for the prediction of acute exacerbations of COPD<br /><br>based on microbiological and clinical analyses</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Composition of the respiratory microbiota in patients with COPD and relation<br /><br>to exacerbation history and clinical parameters<br /><br>- Compositional clustering of respiratory microbiota in relation to disease<br /><br>phenotype<br /><br>- Research changes/shifts in the respiratory microbiota in patients with COPD<br /><br>in the stable phase, during exacerbation and recovery </p><br>