Comparing corticosteroids to placebo for COPD patients needing ventilatory support
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
This study is testing if giving corticosteroids to COPD patients on ventilators can help them have more days off the ventilator and improve their chances of surviving after 28 days.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Versailles Hospital Academic / other |
| Locations | 23 sites (Le Chesnay, Les Yvelines and 22 other locations) |
| Trial ID | NCT04163536 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of intravenous corticosteroids compared to a placebo in increasing the number of ventilator-free days and survival rates at day 28 for patients with severe acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) admitted to intensive care units. Patients aged 40 and older with documented COPD and acute respiratory failure requiring ventilatory support will be enrolled. The study will assess the impact of methylprednisolone on patient outcomes in a critical care setting.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40 and older with a confirmed diagnosis of COPD and acute respiratory failure requiring ventilatory support.
Not a fit: Patients with COPD who do not require ventilatory support or are under 40 years of age may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery times and survival rates for COPD patients experiencing severe exacerbations.
How similar studies have performed: Previous studies have shown mixed results regarding the use of corticosteroids in COPD exacerbations, making this approach both relevant and potentially novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Le Chesnay, Les Yvelines and 22 other locations
- André Mignot Hospital, Intensive care unit — Le Chesnay, Les Yvelines, France (Recruiting)
- CHU Angers — Angers, France (Recruiting)
- CH métropole savoie — Chambéry, France (Not_yet_recruiting)
- CHU Louis Mourier — Colombes, France (Recruiting)
- CHU Henri mondor — Créteil, France (Not_yet_recruiting)
- CHU Dijon — Dijon, France (Recruiting)
- CHU Grenoble — Grenoble, France (Recruiting)
- CHD Vendée — La Roche-sur-Yon, France (Recruiting)
- CHU de Bicêtre — Le Kremlin-Bicêtre, France (Recruiting)
- CH Le Mans — Le Mans, France (Recruiting)
- CHRU lille — Lille, France (Recruiting)
- CHU Lyon — Lyon, France (Recruiting)
- CH d'Annecy Genevois — Metz-Tessy, France (Recruiting)
- CHU Nantes — Nantes, France (Not_yet_recruiting)
- CHR orléans — Orléans, France (Recruiting)
- CHU Cochin — Paris, France (Recruiting)
- Hôpital européen Georges pompidou — Paris, France (Recruiting)
- Pitié-Salpêtrière — Paris, France (Recruiting)
- CHU Poitiers — Poitiers, France (Recruiting)
- CHU de Rennes — Rennes, France (Recruiting)
- CHU de Rouen — Rouen, France (Not_yet_recruiting)
- Hopital Foch — Suresnes, France (Active_not_recruiting)
- CHRU Tours — Tours, France (Recruiting)
Study contacts
- Study coordinator: virginie chatagner
- Email: vchatagner@ght78sud.fr
- Phone: 0139239776
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.