Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Versailles Hospital (Voir sur ClinicalTrials)
octobre 2021
avril 2025
25 octobre 2026
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 acute on chronic respiratory failure
(ACRF) requiring ventilatory support, either invasive or non-invasive.
Etablissements
Critères
Tous
1. Patients aged ≥ 40 years
2. Strongly suspected or documented COPD, defined by the presence of the following
criterias:
- Persistent respiratory symptoms (dyspnoea, chronic cough or sputum)
- History of exposure to a risk factor such as tobacco smoke
- If available, pulmonary function tests showing airflow limitation not fully
reversible (post-bronchodilator ratio of FEV1/ FVC ratio < 0.7)
3. Severe acute exacerbation, defined by the presence of the two following criteria:
- COPD exacerbation defined by a change in the patient baseline respiratory
symptoms and requiring a change in regular respiratory medication
- Acute respiratory failure (polypnea ≥ 30 breaths.min-1 or use of accessory
respiratory muscles) requiring mechanical ventilation, either invasive or NIV
(implemented because of hypercapnic acidosis with PaCO2 ≥ 45 mmHg and pH ≤
7.35).
4. Admission to an ICU, a step-up unit or a respiratory care unit <24h
5. Written inform consent from the patient or his surrogates. In patients who are not
able to consent on admission an emergency inclusion procedure will be allowed, with
a mandatory delayed consent.
6. Affiliation to (or benefit from) French health insurance system.
Exclusion Criteria:
1. Previous diagnostic of asthma ("GINA" international guidelines)
2. Current and proven active SARS-CoV2 infection
3. Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids,
uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus,
gastro-intestinal ulcer bleeding
4. Underlying disease requiring chronic daily use of systemic steroids
5. Pneumothorax at inclusion
6. Extracorporeal life support (ECMO or ECCO2R) at inclusion
7. Moribund patient
8. Pregnancy
9. Patients protected by law
10. Exclusion period due to other interventional clinical trial enrolment which can
influence primary outcome
11. Previous inclusion in the present study