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CORTICOP_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
EU CTIS ID: 2024-516651-41-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged ≥ 40 years, man or woman
- 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)
- Severe acute exacerbation, 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) 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 mechanical ventilation (possibly already started <24H), either invasive 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 <24h
- 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
- Affiliation to (or benefit from) French health insurance system.
You likely can't join if
- Previous diagnostic of asthma, according to "GINA" international guidelines
- Exclusion period due to other interventional clinical trial enrolment which can influence primary outcome
- Previous inclusion in the present study.
- current and proven SARS-COV2 infection
- Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding
- underlying disease requiring chronic daily use of systemic steroids
See the full eligibility criteria
- Patients aged ≥ 40 years, man or woman
- 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)
- Severe acute exacerbation, 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) 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 mechanical ventilation (possibly already started <24H), either invasive 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 <24h
- 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
- Affiliation to (or benefit from) French health insurance system.
- Previous diagnostic of asthma, according to "GINA" international guidelines
- Exclusion period due to other interventional clinical trial enrolment which can influence primary outcome
- Previous inclusion in the present study.
- current and proven SARS-COV2 infection
- Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding
- underlying disease requiring chronic daily use of systemic steroids
- Pneumothorax at inclusion
- Extracorporeal life support (ECMO or ECCO2R) at randomization
- Moribund patient life expectancy < 3 months
- Pregnancy
- Patients protected by law
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.