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, CORTICOP.

Phase 1

• Conditions: Severe acute exacerbations of Chronic Obstructive Pulmonary Disease; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-001726-99-FR
• Lead Sponsor: Centre Hospitalier de Versailles

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-26
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

1) Patients aged = 40 years, man or woman
2) Strongly suspected or documented COPD defined by all the following criterias :
- Persistent respiratory symptoms (dyspnoea, chronic cough or sputum production)
- History of exposure to a risk factor such as tobacco smoke
- If available, pulmonary function tests showing airflow limitation that is not fully reversible (post-bronchodilator ratio of forced expiratory volume in 1 s (FEV1)/forced vital capacity (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: dyspnoea, cough or sputum (volume or purulence) for at least 24 hours and requiring a change in regular respiratory medication
- Acute respiratory failure (defined by clinical signs of excessive muscle activity: polypnea = 30 breaths /min 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)
- Acute respiratory failure < 24h
4) Admission to an ICU, a step-up unit or a respiratory care unit
5) Written Informed consent from the patient or his surrogates. In patients who are not able to consent on admission (i.e., because of hypercapnic encephalopathy) and in absence of a substitute decision maker, an emergency inclusion procedure will be allowed, with a mandatory delayed consent
6) Affiliation to (or benefit from) French health insurance system.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion Criteria

Patient will not be included if they present any of the following criteria
1) Previous diagnostic of asthma, according to GINA” international guidelines
2) Recent use of systemic corticosteroids, defined by systemic corticosteroids use in the past 7 days
3) Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding
4) Pneumothorax at randomization
5) Extracorporeal life support (ECMO or ECCO2R) at randomization
6) Moribund patient life expectancy < 3 months
7) Pregnancy
8) Patients protected by law
9) Exclusion period due to other clinical trial enrolment which can influence primary outcome
10) Previous inclusion in the present study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Evaluate the effect of corticosteroids administration, as compared to placebo on :<br>- mechanical ventilation and support<br>- side effects of corticosteroids<br>- lenght of stay<br>- mortality<br>- COPD exacerbations case<br><br>;Primary end point(s): Number of ventilator-free days (VFD) and alive.;Timepoint(s) of evaluation of this end point: Day 28;Main Objective: 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.