Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05674994

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

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

110

Participants Needed

29

Research Sites

166 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 18 years of age or older
  • Diagnosis of IPF or likely IPF based on 2018 international recommendations
  • Definite or suspected acute exacerbation of IPF defined by international criteria, including acute worsening of breathing within less than 1 month, new bilateral lung abnormalities on CT, and exclusion of other causes
  • For women of childbearing age, use of effective contraception during the study
  • Affiliated to social security
  • Ability to understand and sign informed consent or having a relative who can consent if patient is incapacitated
Not Eligible

You will not qualify if you...

  • Identified cause for acute worsening such as infection
  • Known allergy to glucocorticoids or study treatment components
  • Need for or current use of mechanical ventilation
  • Active bacterial, viral, fungal, or parasitic infection (specific viruses like SARS-CoV-2, Influenza A/B, and RSV considered active viral infection)
  • Active cancer
  • On lung transplant waiting list
  • Treatment with glucocorticoids over 1 mg/kg/day for more than 7 days within the last 15 days
  • Participation in another interventional clinical trial
  • Pregnancy or breastfeeding
  • Under tutorship, curatorship, court protection, or deprived of liberty

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 29 locations

1

CHU ANgers

Angers, France

Actively Recruiting

2

CHU de Besancon

Besançon, France

Actively Recruiting

3

Hôpital Avicenne

Bobigny, France

Not Yet Recruiting

4

CHU BOrdeaux

Bordeaux, France

Actively Recruiting

5

CHU Caen

Caen, France

Actively Recruiting

6

CHU Clermont-Ferrand

Clermont-Ferrand, France

Not Yet Recruiting

7

CHIC

Créteil, France

Actively Recruiting

8

CHU de Dijon

Dijon, France

Actively Recruiting

9

CHU Grenoble

Grenoble, France

Not Yet Recruiting

10

CHRU Lille

Lille, France

Not Yet Recruiting

11

Hospices Civils de Lyon

Lyon, France

Actively Recruiting

12

Hôpital Nord

Marseille, France

Actively Recruiting

13

CHU de Montpellier

Montpellier, France

Not Yet Recruiting

14

CHU Nancy

Nancy, France

Actively Recruiting

15

CHU de Nantes

Nantes, France

Not Yet Recruiting

16

CHU Nice

Nice, France

Not Yet Recruiting

17

Hôpital Paris Saint-Joseph

Paris, France, 75014

Actively Recruiting

18

Hôpital Bichat

Paris, France

Actively Recruiting

19

Hôpital Européen Georges Pompidou

Paris, France

Actively Recruiting

20

Hôpital FOCH

Paris, France

Not Yet Recruiting

21

Hôpital Kremiln Bicetre

Paris, France

Actively Recruiting

22

Hôpital Saint-Louis

Paris, France

Not Yet Recruiting

23

Hôpital Tenon

Paris, France

Actively Recruiting

24

CHU Reims

Reims, France

Actively Recruiting

25

CHU Rennes

Rennes, France

Actively Recruiting

26

CHU Rouen

Rouen, France

Not Yet Recruiting

27

CHU Strasbourg

Strasbourg, France

Not Yet Recruiting

28

CHU Toulouse

Toulouse, France

Actively Recruiting

29

CHU Tours

Tours, France

Not Yet Recruiting

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Research Team

J

Jean-Marc NACCACHE, MD

CONTACT

H

Helene BEAUSSIER, PharmD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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