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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00026622

Enrollment

300

Registered

2021-10-08

Start date

2021-10-17

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

J44.0 J44.1 J44.9

Interventions

Group 1: Duration of the study will be one year for each participant. Participants will start the study with a baseline visit in a clinical stable condition. This will consist of a clinical examinatio

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

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

Measure

Time frame

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

—

Countries

Germany, Netherlands

Contacts

Public ContactGernot Rohde

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main

pneumo.studien@unimedizin-ffm.de+49 69 6301 - 6336

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026