Comparison of Corticosteroids vs Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the ICU
Corticop
1 other identifier
interventional
440
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 chronic-obstructive-pulmonary-disease
Started Oct 2021
Longer than P75 for phase_3 chronic-obstructive-pulmonary-disease
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2019
CompletedFirst Posted
Study publicly available on registry
November 14, 2019
CompletedStudy Start
First participant enrolled
October 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedOctober 18, 2023
October 1, 2023
4 years
October 29, 2019
October 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
the number of ventilator-free days (VFD) and alive at day 28.
To determine if the systemic 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.
day 28
Secondary Outcomes (15)
NIV failure rate
day 7
Duration of NIV and of invasive mechanical ventilation
at day 90
Circulatory and renal support-free days and alive at day 28
at day 28
Severe hyperglycemia requiring intravenous insulin during the five first days
during the five first days
Gastro-intestinal bleeding
between inclusion and day 28
- +10 more secondary outcomes
Study Arms (2)
cortisteroids arm
ACTIVE COMPARATORplacebo arm
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients aged ≥ 40 years
- 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)
- ACRF, defined by the presence of the two following criteria:
- COPD exacerbation defined by a change in the patient baseline respiratory symptoms at least 24 hours and requiring a change in regular respiratory medication
- Acute respiratory failure \<24h (polypnea ≥ 30 breaths.min-1 or use of accessory respiratory muscles) requiring ventilatory support, either invasive (implemented because of respiratory distress) or NIV (implemented because of hypercapnic acidosis with PaCO2 ≥ 45 mmHg and pH ≤ 7.35).
- Admission to an ICU, a step-up unit or a respiratory care unit
- Affiliation to (or benefit from) French health insurance system
You may not qualify if:
- Previous diagnostic of asthma, according to "GINA" international guidelines (40)
- Recent use of systemic corticosteroids, defined by systemic corticosteroids use in the past 7 days
- Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding
- Pneumothorax at randomization
- Moribund patient life expectancy \< 3 months
- Pregnancy
- Patients protected by law
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
André Mignot Hospital, Intensive care unit
Le Chesnay, Les Yvelines, 78150, France
CHU Angers
Angers, France
CH métropole savoie
Chambéry, France
CHU Louis Mourier
Colombes, France
CHU Henri mondor
Créteil, France
CHU Dijon
Dijon, France
CHU Grenoble
Grenoble, France
CHD Vendée
La Roche-sur-Yon, France
CHU de Bicêtre
Le Kremlin-Bicêtre, 94270, France
CH Le Mans
Le Mans, France
CHRU lille
Lille, France
CHU Lyon
Lyon, France
CH d'Annecy Genevois
Metz-Tessy, 74370, France
CHU Nantes
Nantes, France
CHR orléans
Orléans, France
CHU Cochin
Paris, France
Hôpital européen Georges pompidou
Paris, France
Pitié-Salpêtrière
Paris, France
CHU Poitiers
Poitiers, France
CHU de Rennes
Rennes, France
CHU de Rouen
Rouen, France
Hopital Foch
Suresnes, France
CHRU Tours
Tours, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- coordinating investigator
Study Record Dates
First Submitted
October 29, 2019
First Posted
November 14, 2019
Study Start
October 25, 2021
Primary Completion
October 25, 2025
Study Completion
March 1, 2026
Last Updated
October 18, 2023
Record last verified: 2023-10