Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation (eo-Drive)
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- STATUS
- Recruiting
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- End date
- Jan 12, 2025
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- participants needed
- 600
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- sponsor
- University Hospital, Montpellier
Summary
The primary objective of this study is to compare treatment failure rates between a group of eosinophilic (eosinophilia > 2% on day 1 of hospitalization) patients hospitalised for a COPD exacerbation treated via corticotherapy versus a similar group treated via placebo.
Secondarily, treatment failure rates will also be compared between a group of non-eosinophilic patients hospitalised for a COPD exacerbation treated via corticotherapy versus a similar group treated via placebo. Study arms will also be compared for additional aspects of efficacy and safety:
- speed of recovery during the initial hospitalization;
- corticosteroid side effects / induced comorbidities;
- changes in symptoms and episodes of exacerbation;
- pulmonary function, oxygen use and ventilation;
- patient trajectories and resource use (e.g. survival, consults, episodes of hospitalization, medications);
- drug consumption (especially as relates to COPD management, exacerbations and induced comorbidities);
- health status, quality of life, activity/disability;
- patient safety / adverse events in general.
Eosinophilia thresholds optimizing the prediction of corticosteroid response and COPD outcomes will be re-evaluated. The relationships between corticosteroid response and key biomarkers (e.g. infectious groups) will be thoroughly explored, including within eosinophil strata. Potential gender subgroups differences will also be evaluated.
Finally, in prevision of further exploratory studies, a biological collection and an imaging library will be created in association with this protocol. The biological collection will be used to explore the genetic basis and physiology linked with treatment response, gender and patient trajectories. The image library will be used as a platform for the exploration of new imaging markers developed, for example, via machine learning and affiliated techniques.
Details
| Condition | COPD Exacerbation |
|---|---|
| Treatment | 5 days of systemic corticotherapy (prednisone), 5 days of placebo |
| Clinical Study Identifier | NCT04234360 |
| Sponsor | University Hospital, Montpellier |
| Last Modified on | 9 April 2023 |
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