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

Versailles Hospital

Status and phase: Enrolling; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Methylprednisolone; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT04163536

P17/15_corticop

Details and patient eligibility

About

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.

Enrollment: 440 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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. 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).

4. Admission to an ICU, a step-up unit or a respiratory care unit

5. 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

• 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
• Extracorporeal life support (ECMO or ECCO2R) at inclusion
• Moribund patient life expectancy < 3 months
• Pregnancy
• Patients protected by law
• Exclusion period due to other interventional clinical trial enrolment which can influence primary outcome
• Previous inclusion in the present study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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440 participants in 2 patient groups, including a placebo group

cortisteroids arm

Active Comparator group

Treatment:

Drug: Methylprednisolone

placebo arm

Placebo Comparator group

Treatment:

Drug: Placebos