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TERMINATED
NCT04234360
PHASE3

Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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

Interventions

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.

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