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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Intercommunal Creteil	Creteil	France
Centre Hospitalier Universitaire De Lille	Lille	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Centre Hospitalier Victor Dupouy	Argenteuil	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Hospital Foch	Suresnes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Centre Hospitalier Le Mans	Le Mans	France
Centre Hospitalier Metropole Savoie	Chambery	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Bretagne Atlantique	Vannes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Clxbuk Hypqhxoeqsb Rlounian Dnbxjsrjehpckt	Angers	France
Cwu dtnymydheenzml	Epagny Metz Tessy	France
Csryud Huhdtcyxnva Uqxlovabbouqo Df Doahx	Dijon	France
Cqeebw Hpectiibkck Rtmfwuyb Ufvtevhdpcgpa Dy Tnynt	Tours	France
Cqs Kfuawpo Bbimukh	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	25.10.2021

Trial locations

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.

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 ID:

2024-516651-41-00

Protocol code:

PHRC-2018-0127

NCT ID:

NCT04163536

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?