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Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation
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.
Official title: Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation: a Double-blind, Randomized, Controlled Trial
Key Details
Gender
All
Age Range
40 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
182
Start Date
2021-10-12
Completion Date
2025-01-30
Last Updated
2026-06-12
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (18)
CHU Amiens
Amiens, France
CHU Brest - Hôpital Caval Blanche
Brest, France
Clinique du Parc
Castelnau-le-Lez, France
CH Libourne
Libourne, France
Hospice Civils de Lyon
Lyon, France
APHM - Hôpital Nord
Marseille, France
CHU Montpellier
Montpellier, France
CHU Nancy
Nancy, France
CHU Nîmes
Nîmes, France
APHP - Hopital Européen Georges Pompidou
Paris, France
APHP - Hôpital BICHAT
Paris, France
APHP - Hôpital Cochin
Paris, France
APHP - Hôpital Universitaire Pitié-Salpétrière
Paris, France
CHU Bordeaux - Hôpital Haut Lévêque
Pessac, France
CHU Reims
Reims, France
CHRU Strasbourg
Strasbourg, France
Hôpital Larrey CHU Toulouse
Toulouse, France
Hôpital Nord Franche-Comté
Trévenans, France