NCT04234360

Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation

Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation: a Double-blind, Randomized, Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD Exacerbation

Interventions

Type	Name	Description
DRUG	5 days of systemic corticotherapy (prednisone)	Patients randomized to this arm will receive 40 mg prednisone per os per day for 5 days. Other aspects of standard, recommended care (e.g. antibiotherapy) are respected.
DRUG	5 days of placebo	Patients randomized to this arm will receive an appropriate placebo per os for 5 days. Other aspects of standard, recommended care (e.g. antibiotherapy) are respected.

Timeline

• Start date: 2021-10-12
• Primary completion: 2024-10-12
• Completion: 2025-01-12
• First posted: 2020-01-21
• Last updated: 2024-01-26

Locations

22 sites across 1 country: France