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Study on the Effects of Methylprednisolone and Placebo on Ventilator Support Duration in Severe COPD Patients in Intensive Care

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for patients with Chronic Obstructive Pulmonary Disease (COPD), a lung condition that makes it hard to breathe. The treatment being tested is a type of medication called corticosteroids, specifically Methylprednisolone, which is given through an injection. This study will compare the effects of corticosteroids to a placebo to see if it helps patients recover faster when they have severe breathing problems and need help from a machine to breathe.

The purpose of the study is to find out if using corticosteroids can increase the number of days patients can breathe on their own without the help of a ventilator within 28 days. Patients in the study will receive either the corticosteroid treatment or a placebo, and their progress will be monitored to see how long they need ventilator support and how well they recover. The study will also look at other factors like the length of hospital stay and any side effects that might occur.

Participants will be closely observed during their time in the hospital, and the study will last for a period of up to five days for the treatment phase. The researchers aim to gather information that could help improve the care and treatment of patients with severe COPD in the future. The study is expected to continue until early 2027, with results being analyzed to determine the effectiveness of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current health condition related to chronic obstructive pulmonary disease (COPD).

    Consent is obtained from the patient or their representative, allowing participation in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the severity of the COPD exacerbation and the need for ventilatory support.

    This assessment may include checking respiratory symptoms and the use of mechanical ventilation.

  3. Step 3

    Treatment administration

    The treatment involves the administration of methylprednisolone and sodium chloride through intravenous injection.

    Methylprednisolone is given as a 120 mg dose, and sodium chloride is used as a solution for injection.

  4. Step 4

    Monitoring and follow-up

    The patient's response to the treatment is monitored, focusing on the number of ventilator-free days and overall health status at day 28.

    Secondary outcomes such as the duration of mechanical ventilation, any complications, and overall recovery are also assessed.

  5. Step 5

    Completion of study participation

    The study participation concludes with a final evaluation of the patient's health status, including any new exacerbations or hospitalizations up to day 90.

    The study aims to determine the effectiveness of corticosteroids in reducing the duration of ventilatory support in severe COPD exacerbations.

Who can join the trial?

9 criteria

  • Patients must be **40 years or older**, whether male or female.
  • Patients should have a **strong suspicion or documented diagnosis of COPD** (chronic obstructive pulmonary disease), which includes:
    • Ongoing breathing problems like shortness of breath, a long-term cough, or producing mucus.
    • A history of exposure to risk factors, such as smoking.
    • If available, lung function tests showing limited airflow that doesn't fully improve with treatment.
    • Patients must have a **severe sudden worsening of COPD**, shown by:
      • A noticeable change in breathing symptoms, like increased shortness of breath, cough, or mucus production, needing a change in usual breathing medication.
      • **Acute respiratory failure**, which means the body is struggling to breathe, shown by fast breathing (30 breaths per minute or more) or using extra muscles to breathe, needing mechanical help to breathe, either through a machine or a mask, due to high carbon dioxide levels in the blood and low blood pH.
      • Patients must be admitted to an **ICU (Intensive Care Unit)**, a step-up unit, or a respiratory care unit within 24 hours.
      • Patients or their representatives must provide **written informed consent**. If the patient cannot consent due to a condition like confusion from high carbon dioxide levels, and no representative is available, an emergency procedure for inclusion is allowed, with consent obtained later.
      • Patients must be **affiliated with or benefit from the French health insurance system**.

Who cannot join the trial?

4 criteria

  • Patients who do not have COPD (Chronic Obstructive Pulmonary Disease) cannot participate.
  • Patients who are not admitted to an ICU (Intensive Care Unit), a step-up unit, or a respiratory care unit for an ACRF (Acute Chronic Respiratory Failure) requiring ventilatory support cannot participate.
  • Patients who are not in the age range specified by the study cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

Corticosteroids are medications used in this trial to help reduce inflammation in the lungs of patients with severe COPD exacerbations. The goal is to see if these medications can decrease the amount of time patients need ventilatory support and improve their chances of being alive and free from ventilators by day 28.

What is already known about the treatment

Corticosteroids – Corticosteroids are typically administered systemically, either orally or through intravenous injection, depending on the severity of the condition. They are widely recognized in medical literature and are commonly used in the treatment of various inflammatory and autoimmune conditions. In this clinical trial, they are being evaluated for their effectiveness in reducing the duration of ventilatory support in patients with severe acute exacerbations of chronic obstructive pulmonary disease (COPD) in intensive care settings. Corticosteroids work by suppressing inflammation at the molecular level, primarily by inhibiting the production of substances that trigger inflammatory responses. They belong to the pharmacological class of anti-inflammatory agents.

Investigated diseases

Chronic Obstructive Pulmonary Disease (COPD) – This is a long-term lung disease that makes it hard to breathe. It is characterized by a persistent blockage of airflow from the lungs, which can lead to shortness of breath, coughing, and wheezing. The disease progresses slowly and can worsen over time, especially if exposure to lung irritants like cigarette smoke continues. As COPD advances, individuals may experience increased difficulty in performing daily activities due to breathing challenges. The disease often involves episodes of acute exacerbations, where symptoms suddenly become worse and may require medical intervention. Over time, COPD can lead to decreased lung function and increased risk of respiratory infections.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516651-41-00Protocol codePHRC-2018-0127Estimated enrolment440 patientsSponsorCentre Hospitalier De Versailles

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).