No registrations found.
ID
Source
Brief title
Health condition
COPD
Sponsors and support
Intervention
Outcome measures
Primary outcome
Accuracy of risk assessment for the prediction of acute exacerbations of COPD based on microbiological and clinical analyses.
Secondary outcome
• 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
Background summary
COPD is a devastating disease for which no curative treatments are available. Global prevalence of COPD is estimated at 12% and is expected to rise over the next decades, due to increasing smoking behavior in developing countries and aging populations in high-income countries. The clinical course of COPD is characterized by exacerbations, acute worsening of symptoms. Exacerbations incur extreme costs to society due to the need for acute treatment and hospitalisation. Finally, exacerbations play a crucial role in the progression of lung function deterioration. About 10% of patients hospitalized with exacerbation will not survive, while another 15% will not survive beyond 1 year.
Prevention of exacerbations is one of the key aims of COPD treatment but is largely ineffective. Insufficient understanding of the pathobiology and heterogeneity of these events and lack of validated biomarkers to predict and optimize treatment of exacerbations contribute to this tremendous unmet need. The onset of exacerbations was recently shown to coincide with a shift in the respiratory tract microbiota (RTM). Regular monitoring of the RTM in exacerbation prone COPD patients thus represents an opportunity to predict exacerbation occurrence earlier. This enables clinicians to initiate appropriate therapies to prevent exacerbations.
An easy-to-use technique for the analysis of the RTM in daily clinical practice will enable appropriate therapy early on and reduce the risk of life-threatening exacerbations.
REDALERT’s goal is to combine the ISPro technology and geneXplain platform to develop an integrated solution for routine RTM analysis with:
A) novel processing methods for ISPro to accurately characterize the RTM and the relative abundance and shifts therein of microbiota
B) clinical decision-making algorithms based on the geneXplain platform to predict exacerbations from RTM samples and associated clinical patient data
C) integration with two main hospital information systems to include additional patient health data.
Study objective
A novel approach/algorithm for individualised risk assessment of COPD exacerbations, which integrates both microbiological data and clinical information, improves the accuracy of exacerbation prediction in COPD patients over methods based on clinical parameters alone.
Study design
9
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
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9801 |
| Other | METC azM/UM : METC azM/UM 068 |