drugset / Trial / NCT04163536

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

NCT04163536 ↗

Phase 3 Unknown 440 enrolled Versailles Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-10-25
Primary completion
2025-10-25
Completion
2026-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylprednisolone Other / unclassified 1 mg/kg Intravenous