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Study on the Effects of Methylprednisolone and Prednisone for Treating Acute Flare-Ups in Idiopathic Pulmonary Fibrosis Patients

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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 group of medications called glucocorticoids on a lung disease known as Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition where the lungs become scarred and breathing becomes difficult. The trial will compare the use of glucocorticoids to a placebo in treating sudden worsening of this disease, known as an acute exacerbation. The glucocorticoids being studied include Methylprednisolone, which is given as an injection, and Liquid Prednisone, which is taken by mouth. The purpose of the study is to see if these medications can help reduce the risk of death within 30 days for patients experiencing an acute exacerbation of IPF.

Participants in the study will receive either the glucocorticoid treatment or a placebo. The study will monitor the participants' health over a period of time, focusing on their survival rate at 30 days. Other aspects of their health will also be observed, such as their lung function, any need for intensive care, and overall well-being. The study aims to gather information on how effective glucocorticoids are in managing the acute worsening of IPF and whether they can improve the outcomes for patients.

Throughout the study, various health parameters will be checked, including blood sugar levels, heart rate, and blood pressure. The study will also look at any changes in the participants' lung condition and their overall health status. This research hopes to provide valuable insights into the treatment of IPF and potentially improve the quality of life for those affected by this challenging condition.

The research process

The trial runs in 7 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 criteria such as age (18 years or older), diagnosis of idiopathic pulmonary fibrosis (IPF), and the ability to provide informed consent.

    Women of childbearing age must use effective contraception during the study.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either glucocorticoids or a placebo. This process ensures that the study results are unbiased.

  3. Step 3

    Treatment administration

    If assigned to the glucocorticoid group, the treatment involves methylprednisolone administered as an intravenous infusion and prednisone taken orally.

    The specific dosage and frequency are determined by the study protocol and medical team.

  4. Step 4

    Monitoring and assessments

    Participants undergo regular monitoring, including daily checks of blood glucose levels and cardiovascular health (heart rate and blood pressure).

    Neuropsychological assessments and evaluations of lung function are conducted periodically.

  5. Step 5

    Primary evaluation

    The main goal is to assess the effect of glucocorticoids on mortality by Day 30.

    Vital status is checked at Day 30 and Day 90, with additional assessments of overall health and disease progression.

  6. Step 6

    Secondary evaluations

    Secondary outcomes include the need for intensive care, use of mechanical ventilation, and length of hospital stay.

    Other evaluations include changes in lung function, presence of infections, and psychological well-being.

  7. Step 7

    Completion of study

    The study concludes with a final assessment at Day 90, focusing on overall health, disease progression, and any adverse effects experienced during the trial.

Who can join the trial?

6 criteria

  • The patient must be **18 years of age or older**.
  • The patient must have a diagnosis of **Idiopathic Pulmonary Fibrosis (IPF)**, which is a lung disease, or a likely diagnosis based on 2018 international guidelines.
  • The patient must have a **definite or suspected Acute Exacerbation (AE)**, which means a sudden worsening of the lung condition, as defined by international criteria, after ruling out other possible causes.
  • For women who can have children, they must use **effective birth control** during the study.
  • The patient must be **affiliated with social security**, meaning they have access to healthcare coverage.
  • The patient must be able to **understand and sign a written informed consent form**. If the patient is unable to do so, a relative who understands and can sign the form must do it on their behalf.

Who cannot join the trial?

8 criteria

  • Patients who have a different lung condition other than Idiopathic Pulmonary Fibrosis (IPF) cannot participate. IPF is a disease that causes scarring in the lungs.
  • Patients who are not experiencing an acute exacerbation of IPF cannot participate. An acute exacerbation is a sudden worsening of symptoms.
  • Patients who are under the age of 18 or over the age of 80 cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial within the last 30 days cannot participate.
  • Patients who have a history of severe allergic reactions to glucocorticoids cannot participate. Glucocorticoids are a type of medication used to reduce inflammation.
  • Patients who have a serious medical condition that might interfere with the study cannot participate.
  • Patients who are unable to follow the study procedures cannot participate.
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Investigated drugs

Glucocorticoids are a type of medication used to reduce inflammation in the body. In this clinical trial, they are being tested to see if they can help improve survival rates in patients experiencing a sudden worsening of idiopathic pulmonary fibrosis, a lung disease. The goal is to determine if glucocorticoids can effectively lower the risk of death within 30 days of treatment.

What is already known about the treatment

Glucocorticoids – Glucocorticoids are typically administered orally or intravenously, depending on the severity of the condition being treated. They are currently being studied in clinical trials for their effectiveness in treating acute exacerbations of idiopathic pulmonary fibrosis (IPF). These medications are primarily used to reduce inflammation and suppress the immune system. At the molecular level, glucocorticoids work by binding to glucocorticoid receptors, which then interact with DNA to regulate the expression of specific genes that control inflammation. They are classified as corticosteroids, a type of steroid hormone.

Investigated diseases

Idiopathic Pulmonary Fibrosis – Idiopathic Pulmonary Fibrosis (IPF) is a chronic lung disease characterized by the thickening and scarring of lung tissue, leading to a progressive decline in lung function. The exact cause of IPF is unknown, and it primarily affects middle-aged and older adults. As the disease progresses, the scarring becomes more extensive, making it increasingly difficult for the lungs to transfer oxygen into the bloodstream. Patients often experience symptoms such as shortness of breath, a persistent dry cough, and fatigue. Over time, the disease can lead to severe breathing difficulties and reduced quality of life. The progression of IPF varies among individuals, with some experiencing a rapid decline in lung function while others have a slower progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514799-42-00Protocol codeEXAFIP2Estimated enrolment110 patientsSponsorGIE Groupe hospitalier Paris Saint-Joseph/Vinci

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