NCT04163536

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

Comparison of Corticosteroids Versus Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the Intensive Care Unit: a Multicentre Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Versailles Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to determine if the systemic (intravenous) administration of corticosteroids, as compared to placebo, increases the number of ventilator-free days (VFD) and alive at day 28 in COPD patients admitted to an ICU, a step-up unit or a respiratory care unit for an ACRF requiring ventilatory support, either invasive or non-invasive.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-25
• Primary completion: 2025-10-25
• Completion: 2026-03-01
• First posted: 2019-11-14
• Last updated: 2023-10-18

Locations

23 sites across 1 country: France