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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26474

Enrollment

300

Registered

2021-10-18

Start date

2021-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: • Age = 18 years • Written informed consent • Physician-confirmed diagnosis of COPD (spirometry) (FEV1= 80% predicted) • Smoking history: Min. 10 packyears

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Accuracy of risk assessment for the prediction of acute exacerbations of COPD based on microbiological and clinical analyses.	—

Secondary

Measure	Time frame
• Composition of the respiratory microbiota in patients with COPD and relation to exacerbation history and clinical parameters • Compositional clustering of respiratory microbiota in relation to disease phenotype • Stability of the respiratory microbiota in patients with COPD in the stable phase, during exacerbation and recovery • Host gene signatures in relation to respiratory microbiota profile	—

Measure

Time frame

• Composition of the respiratory microbiota in patients with COPD and relation to exacerbation history and clinical parameters • Compositional clustering of respiratory microbiota in relation to disease phenotype • Stability of the respiratory microbiota in patients with COPD in the stable phase, during exacerbation and recovery • Host gene signatures in relation to respiratory microbiota profile

—

Contacts

Public ContactCarmen Reumkens

Maastricht University

c.reumkens@maastrichtuniversity.nl043 3876644

Outcome results