Comparison of Corticosteroids vs Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the ICU

PHASE3RecruitingINTERVENTIONAL
Enrollment

440

Participants

Timeline

Start Date

October 25, 2021

Primary Completion Date

October 25, 2025

Study Completion Date

March 1, 2026

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

Methylprednisolone

In the experimental group, methylprednisolone will be administered intravenously for 5 days at a dose of 1 mg/kg/day. Methylprednisolone will be provided for reconstitution and dilution in 50 ml of NaCl 0.9% solution and administered over 15 minutes, once a day.

DRUG

Placebos

in the control group, placebo will be administered intravenously for 5 days. Placebo will be identical (color and aspect) to experimental substance, will be provide as a 50 mL of NaCl 0.9% solution and administered intravenously over 15 minutes, once a day.

Trial Locations (23)

74370

RECRUITING

CH d'Annecy Genevois, Metz-Tessy

78150

RECRUITING

André Mignot Hospital, Intensive care unit, Le Chesnay

94270

RECRUITING

CHU de Bicêtre, Le Kremlin-Bicêtre

Unknown

RECRUITING

CHU Angers, Angers

NOT_YET_RECRUITING

CH métropole savoie, Chambéry

RECRUITING

CHU Louis Mourier, Colombes

NOT_YET_RECRUITING

CHU Henri mondor, Créteil

RECRUITING

CHU Dijon, Dijon

RECRUITING

CHU Grenoble, Grenoble

RECRUITING

CHD Vendée, La Roche-sur-Yon

RECRUITING

CH Le Mans, Le Mans

RECRUITING

CHRU lille, Lille

RECRUITING

CHU Lyon, Lyon

NOT_YET_RECRUITING

CHU Nantes, Nantes

RECRUITING

CHR orléans, Orléans

RECRUITING

CHU Cochin, Paris

RECRUITING

Hôpital européen Georges pompidou, Paris

RECRUITING

Pitié-Salpêtrière, Paris

RECRUITING

CHU Poitiers, Poitiers

RECRUITING

CHU de Rennes, Rennes

NOT_YET_RECRUITING

CHU de Rouen, Rouen

ACTIVE_NOT_RECRUITING

Hopital Foch, Suresnes

RECRUITING

CHRU Tours, Tours

All Listed Sponsors
lead

Versailles Hospital

OTHER