METHYLPREDNISOLONE HYDROGEN SUCCINATE for Chronic obstructive pulmonary disease

Inclusion criteria

• {"criterion_text":"- Patients aged ≥ 40 years, man or woman\n- 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)\n- 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)\n- Admission to an ICU, a step-up unit or a respiratory care unit <24h\n- 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\n- Affiliation to (or benefit from) French health insurance system."}

Exclusion criteria

• {"criterion_text":"- Previous diagnostic of asthma, according to \"GINA\" international guidelines\n- current and proven SARS-COV2 infection\n- Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding\n- underlying disease requiring chronic daily use of systemic steroids\n- Pneumothorax at inclusion\n- Extracorporeal life support (ECMO or ECCO2R) at randomization\n- Moribund patient life expectancy < 3 months\n- Pregnancy\n- Patients protected by law\n- Exclusion period due to other interventional clinical trial enrolment which can influence primary outcome\n- Previous inclusion in the present study."}

Primary endpoints

• {"endpoint_text":"- Number of ventilator-free days (VFD) and alive.","definition_or_measurement_approach":"Ventilator-free days and alive at day 28 (VFD alive at Day 28)."}

Secondary endpoints

• {"endpoint_text":"- NIV failure rate, defined by intubation","definition_or_measurement_approach":"Defined by need for intubation (failure of non-invasive ventilation; intubation before Day 7 in translation)."}
• {"endpoint_text":"- Duration of NIV and of invasive mechanical ventilation","definition_or_measurement_approach":"Measured duration (days) of non-invasive ventilation and invasive mechanical ventilation."}
• {"endpoint_text":"- Circulatory support-free days and alive at day 28","definition_or_measurement_approach":"Number of days alive and without circulatory (or renal) support at Day 28."}
• {"endpoint_text":"- Severe hyperglycemia requiring intravenous insulin before day 5","definition_or_measurement_approach":"Occurrence of severe hyperglycaemia necessitating IV insulin during first 5 days."}
• {"endpoint_text":"- Gastro-intestinal bleeding: acute loss of 2 g/dL of hemoglobin requiring red blood cell transfusion or gastroscopic evaluation","definition_or_measurement_approach":"Acute GI blood loss of 2 g/dL Hb requiring RBC transfusion or gastroscopy."}
• {"endpoint_text":"- Uncontrolled arterial hypertension: unusual hypertension requiring to introduce/add antihypertensive medication (compared to usual medications)","definition_or_measurement_approach":"New/unusual hypertension requiring initiation or addition of antihypertensive therapy vs baseline medications."}
• {"endpoint_text":"- ICU acquired weakness (MRC-score) assessed on day 28 or at the time of ICU discharge","definition_or_measurement_approach":"Assessment of ICU-acquired weakness using MRC-score at Day 28 or at ICU discharge if earlier."}
• {"endpoint_text":"- ICU-acquired infections (especially Ventilator-Associated Pneumonia)","definition_or_measurement_approach":"Incidence of ICU-acquired infections, including ventilator-associated pneumonia, catheter-related infection, bacteremia, etc."}
• {"endpoint_text":"- Length of ICU and hospital stay","definition_or_measurement_approach":"Duration (days) of ICU stay and total hospital stay."}
• {"endpoint_text":"- ICU and hospital mortality","definition_or_measurement_approach":"Mortality during ICU stay and during hospitalisation."}
• {"endpoint_text":"- Day 28 and Day 90 mortality","definition_or_measurement_approach":"All-cause mortality assessed at Day 28 and Day 90."}
• {"endpoint_text":"- Standardized mortality ratio (SMR)","definition_or_measurement_approach":"Standardized mortality ratio calculation (method not specified in provided text)."}
• {"endpoint_text":"- Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90","definition_or_measurement_approach":"Count of new COPD exacerbations or hospitalisations occurring between discharge and Day 90."}
• {"endpoint_text":"- Dyspnea and comfort (patient reported outcome) at Day 90","definition_or_measurement_approach":"Patient-reported dyspnea and comfort measures at Day 90 (instruments not specified)."}

France

Earliest CTIS Part Ii Submission Date

14-08-2024

Latest Decision Or Authorization Date

23-09-2025

Processing Time Days

405

Number Of Sites

25

Number Of Participants

440

Primary sponsor

Full Name

Centre Hospitalier De Versailles

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France