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

Conditions: J44.0
J44.1
J44.9
Chronic obstructive pulmonary disease with acute lower respiratory infection
Chronic obstructive pulmonary disease with acute exacerbation, unspecified
Chronic obstructive pulmonary disease, unspecified

Registration Number: DRKS00026622

Lead Sponsor: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. Written informed consent
2. Physician-confirmed diagnosis of COPD (spirometry) (FEV1 = 80% predicted)
3. Smoking history: Min. 10 packyears

Exclusion Criteria

1.Inability to understand the nature, scope, and possible consequences of the study
2. Life expectancy of less than 12 months
3. Newly diagnosed active pulmonary tuberculosis within the last 12 months
4. Unstable cardiopulmonary or metabolic co-morbidities
5. Macrolide maintenance treatment

Study & Design

Study Type: observational

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
1. Composition of the respiratory microbiota in patients with COPD and relation to exacerbation history and clinical parameters.<br>2. Compositional clustering of respiratory microbiota in relation to disease phenotype<br>3. Stability of the respiratory microbiota in patients with COPD in the stable phase, during exacerbation and recovery <br>4. Host gene signatures in relation to respiratory microbiota profile