What is glucocorticoids studying for acute exacerbation of idiopathic pulmonary fibrosis?

This clinical trial is evaluating whether glucocorticoids can reduce mortality in patients experiencing an acute worsening of idiopathic pulmonary fibrosis. Researchers aim to clarify if steroid treatment improves survival compared to placebo. The study is sponsored by Fondation Hôpital Saint-Joseph and addresses an urgent need for effective therapy in this severe lung condition.

Who may be eligible for this acute exacerbation of idiopathic pulmonary fibrosis clinical trial?

Adults aged 18 years and older with a confirmed or likely diagnosis of idiopathic pulmonary fibrosis experiencing an acute worsening of symptoms may be eligible. The trial includes all genders and excludes those on mechanical ventilation or with active infections or cancer. Please review eligibility criteria for more details.

Is there any cost to participate in this acute exacerbation of idiopathic pulmonary fibrosis clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. However, personal travel expenses to and from the study site may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID05674994

Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis a Randomized Controlled Trial

Led by Fondation Hôpital Saint-Joseph · Updated on 2026-03-02

110

Participants Needed

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Acute exacerbation of idiopathic pulmonary fibrosis AE-IPF is a serious condition with a poor outlook, where more than half of patients may die within three months. There is currently no proven effective treatment for AE-IPF, and the use of glucocorticoids is debated due to unclear benefits and possible harmful effects seen with other immunosuppressants. This trial aims to clarify whether glucocorticoids improve survival in AE-IPF by comparing them to a placebo in a randomized controlled study. Participants will be randomly assigned to receive either high-dose glucocorticoids or a placebo. Those in the glucocorticoid group will receive intravenous methylprednisolone at 10 mgkgday up to 1000 mgday for three days, followed by a slow tapering oral prednisone schedule over the next 27 days. The placebo group will receive matching intravenous and oral placebo treatments on the same schedule. The randomization is stratified based on disease severity and use of antifibrotic therapy. During the study, patients will be monitored for mortality at 30 days as the primary outcome, with additional assessments at 90 days including time to death, need for intensive care or ventilation, lung function tests, imaging, and safety measures such as infection and other complications. The trial collects data on respiratory symptoms, anxiety, depression, and overall clinical status at various timepoints. Participants will be followed through hospitalization and up to three months after treatment starts to evaluate the effects and safety of the treatments.

CONDITIONS

Brief Title

Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patient is 18 years of age or older
Diagnosis of idiopathic pulmonary fibrosis or likely IPF based on 2018 international recommendations
Definite or suspected acute exacerbation of IPF defined by international working group criteria
For women of childbearing age: use of effective contraception during the study
Affiliation to social security
Ability to understand and sign informed consent (or a relative can consent if patient is incapacitated)

You will not qualify if you...

Identified cause for acute worsening such as infection
Known allergy to glucocorticoids or any study treatment component
Requirement for mechanical ventilation or currently on mechanical ventilation
Active bacterial, viral, fungal, or parasitic infection (except certain common respiratory viruses)
Active cancer
On a lung transplant waiting list
Use of glucocorticoids over 1 mg/kg/day for more than 7 days in the past 15 days
Participation in another interventional clinical trial
Pregnancy or breastfeeding
Under legal tutorship, curatorship, court protection, or deprived of liberty

Research Team

Jean-Marc NACCACHE, MD

Helene BEAUSSIER, PharmD, PhD

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