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 study about?

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.

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 randomization

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

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Hopital Tenon Paris France
Hospital Foch Suresnes France
Centre Hospitalier Regional Universitaire Besançon France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
16.10.2023

Trial locations

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.

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 ID:
2024-514799-42-00
Protocol code:
EXAFIP2
NCT ID:
NCT05674994
Trial Phase:
Therapeutic exploratory (Phase II)

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