Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation
Status:
Recruiting
Trial end date:
2024-01-12
Target enrollment:
Participant gender:
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.