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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Acute Exacerbation of Idiopathic Pulmonary Fibrosis

In brief

Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is associated with a poor prognosis, with a 3-month mortality rate of over 50%. To date, no treatment has been proven to be effective in AI-FPI. The interest of glucocorticoids is controversial and needs to be confirmed. This confirmation is mandatory to validate the improvement of the prognosis of EA-IPF under this treatment but also to search for unsuspected deleterious effects as it has been shown with immunosuppressants in stable idiopathic pulmonary fibrosis.

Key facts

Study ID

NCT05674994

Run by

Fondation Hôpital Saint-Joseph

People needed

110

Starts

2023-10-26

Expected to finish

2026-12-31

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is ≥ 18 years of age
• IPF or IPF (likely) diagnosis defined on 2018 international recommendations
• Definite or suspected Acute Exacerbation defined by the international working group criteria after exclusion of alternative diagnoses of acute worsening
• The criteria of IPF-AE are as follows:
• Previous or concurrent diagnosis of IPF (a)
• Acute worsening or development of dyspnea typically < 1-month duration
• Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern (b)
• Deterioration not fully explained by cardiac failure or fluid overload Patients who fail to meet all 4 criteria due to missing computed tomography should be considered as having "suspected Acute Exacerbation".
• If the diagnosis of IPF is not previously established, this criterion can be met by the presence of radiologic and/or histopathologic changes consistent with usual interstitial pneumonia pattern on the current evaluation.
• If no previous computed tomography is available, the qualifier "new" can be dropped from the third criterion.
• For women of childbearing age: efficient contraception for the duration of the study*
• Effective contraception is defined as any contraceptive method that is used consistently and appropriately and has a low failure rate (i.e., less than 1% per year)
• Affiliation to the social security
• Patient able to understand and sign a written informed consent form or in case of incapacity of the patient to a relative whom understand and sign a written informed consent form

You may not qualify if…

• Identified etiology for acute worsening (i.e.: infectious disease)
• Known hypersensitivity to glucocorticoids or to any component of the study treatment
• Patient requiring mechanical ventilation or already on mechanical ventilation
• Active bacterial, viral, fungal or parasitic infection. On swab collected, only positive for SARS-CoV-2, Influenzae A, Influenzae B and Respiratory Syncytial Virus (RSV) result, are considered active viral infection. The others viruses (i.e. Rhinovirus, Adenovirus…) are not considered to be responsible of pneumonia.
• Active cancer
• Patient on a lung transplantation waiting list
• Treatment with glucocorticoids > 1 mg/kg/d from more than 7 days in the last 15 days
• Patient participating to another interventional clinical trial
• Documented pregnancy or lactation
• Patient under tutorship or curatorship
• Patient deprived of liberty
• Patient under court protection

Where it is running

• Hôpital Bichat — Paris, France (enrolling)
• Hôpital Européen Georges Pompidou — Paris, France (enrolling)
• CHU BOrdeaux — Bordeaux, France (enrolling)
• Hôpital Kremiln Bicetre — Paris, France (enrolling)
• CHU Caen — Caen, France (enrolling)
• Hôpital Tenon — Paris, France (enrolling)
• CHU Reims — Reims, France (enrolling)
• CHU Rennes — Rennes, France (enrolling)
• Hospices Civils de Lyon — Lyon, France (enrolling)
• Hôpital Nord — Marseille, France (enrolling)
• CHU Toulouse — Toulouse, France (enrolling)
• CHU ANgers — Angers, France (enrolling)
• CHU de Besancon — Besançon, France (enrolling)
• CHU Nancy — Nancy, France (enrolling)
• CHIC — Créteil, France (enrolling)
• CHU de Dijon — Dijon, France (enrolling)
• Hôpital Paris Saint-Joseph — Paris, France (enrolling)
• CHU Tours — Tours, France
• Hôpital Avicenne — Bobigny, France
• CHU Clermont-Ferrand — Clermont-Ferrand, France
• CHU Grenoble — Grenoble, France
• CHRU Lille — Lille, France
• CHU de Montpellier — Montpellier, France
• CHU de Nantes — Nantes, France
• CHU Nice — Nice, France

Full record on ClinicalTrials.gov

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