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Taking people in FrancePhase 3

Tests corticosteroids against placebo for sudden worsening of pulmonary fibrosis

Tests steroid drugs against a placebo in adults with sudden worsening of lung scarring.

Key facts

Who runs it
Fondation Hôpital Saint-Joseph
Where
Angers, Besancon Cedex, Bobigny, Bron, Caen Cedex 9, Clermont Ferrand Cedex 1, Créteil, Dijon, Grenoble Cedex 9, Le Kremlin-Bicetre, Lille, Marseille, Montpellier Cedex 5, Nancy, Nice, Paris, Paris Cedex 14, Paris Cedex 18, Paris Cedex 20, Pessac, Reims, Rennes, Rouen Cedex, Saint-Herblain, Strasbourg Cedex, Suresnes, Toulouse Cedex 9, and Tours, FranceSee the 28 sites
Registry title
Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Status
Recruiting
Phase
Phase 3
People taking part
110 people, planned
Started
26 Oct 2023
Expected to end
31 Dec 2026
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Methylprednisone/Prednisone
  • Placebo
Record updated
2 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with idiopathic pulmonary fibrosis (IPF) whose breathing has suddenly got worse (acute exacerbation). It compares glucocorticoids with a placebo.

Age
18 years or older
Sex
All sexes can join.
Disease stage
IPF or likely IPF, with a definite or suspected acute exacerbation. Breathlessness usually worsened in less than 1 month, and no other cause was found.
Earlier treatment
Cannot have taken glucocorticoids above 1 mg/kg/d for more than 7 days in the last 15 days.

Main reasons for not taking part

  • Another known cause for the worsening, such as an infection
  • Needs a breathing machine (mechanical ventilation) or is already on one
  • Active cancer
  • On a lung transplant waiting list
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patient on a lung transplantation waiting list
  • Treatment with glucocorticoids > 1 mg/kg/d from more than 7 days in the last 15 days
  • Identified etiology for acute worsening (i.e.: infectious disease)
  • Known hypersensitivity to glucocorticoids or to any component of the study treatment
  • 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 requiring mechanical ventilation or already on mechanical ventilation
  • 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 in France

  • Centre Hospitalier Universitaire D'AngersAngers, FranceTaking people
  • Centre Hospitalier Regional UniversitaireBesancon Cedex, FranceTaking people
  • Assistance Publique Hopitaux De ParisBobigny, FranceTaking people
  • Hospices Civils de LyonBron, FranceTaking people
  • Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9, FranceTaking people
  • University Hospital Of Clermont-FerrandClermont Ferrand Cedex 1, FranceTaking people
  • Centre Hospitalier Intercommunal CréteilCréteil, FranceTaking people
  • Centre Hospitalier Universitaire de DijonDijon, FranceTaking people
  • Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranceTaking people
  • Assistance Publique Hopitaux De ParisLe Kremlin-Bicetre, FranceTaking people
  • Centre Hospitalier Universitaire de LilleLille, FranceTaking people
  • Centre Hospitalier Regional De MarseilleMarseille, FranceTaking people
  • Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceTaking people
  • CHRU de NancyNancy, FranceTaking people
  • Centre Hospitalier Universitaire de NiceNice, FranceTaking people
  • Assistance Publique Hopitaux de ParisParis, FranceTaking people
  • GIE Groupe hospitalier Paris Saint-Joseph/VinciParis Cedex 14, FranceTaking people
  • Assistance Publique Hopitaux De ParisParis Cedex 18, FranceTaking people
  • Hopital TenonParis Cedex 20, FranceTaking people
  • Centre Hospitalier Universitaire de BordeauxPessac, FranceTaking people
  • Centre Hospitalier Universitaire ReimsReims, FranceTaking people
  • Centre Hospitalier Universitaire de RennesRennes, FranceTaking people
  • Centre Hospitalier Universitaire RouenRouen Cedex, FranceTaking people
  • Centre Hospitalier Universitaire de NantesSaint-Herblain, FranceTaking people
  • Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex, FranceTaking people
  • Hospital FochSuresnes, FranceTaking people
  • Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceTaking people
  • Centre Hospitalier Régional Universitaire de ToursTours, FranceTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • MethylPrednisone/PrednisoneTreatment being tested

    * Day 1, 2 and 3: Intravenous Methylprednisolone 10 mg/kg/d (without exceeding 1000 mg/d) Vials of injectable solution of methylprednisolone® are diluted in 100 ml of NaCl 0.9% or G5%. Perfusion duration is between 20 to 30 minutes. The commercialized form for methylprednisolone injectable solution is not imposed and is taken from the stock of each pharmacy of the participating centers. * From day 4 to Day 30: Oral Prednisone slow tappering * 1 mg/kg/d for 7 days * 0.5 mg/kg/d for 7 days * 0.25 mg/kg/d for 7 days, * 10 mg/d until Day 30. For 10mg/kg, 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg; rounding to 5 decimal lower if decimal ≤ 7 and the top ten if decimal ≥ 8.

  • PlaceboPlacebo, for comparison

    * Day 1, 2 and 3: Intravenous Methylprednisolone-Placebo * From Day 4 to Day 30: Oral Prednisone-Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Randomized Controlled Trial
Plain-language title
Tests corticosteroids against placebo for sudden worsening of pulmonary fibrosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 March 2026