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Search / Trial NCT05674994

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

Launched by FONDATION HÔPITAL SAINT-JOSEPH · Dec 29, 2022

Trial Information

Current as of July 12, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating whether glucocorticoids, a type of medication often used to reduce inflammation, are effective in treating acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF). AE-IPF is a serious condition where symptoms suddenly worsen, and unfortunately, it can lead to a high risk of death within just three months. Currently, there are no proven treatments for this condition, and the researchers are looking to see if glucocorticoids can improve patient outcomes while also checking for any harmful side effects.

To participate in this study, you must be at least 18 years old and have been diagnosed with idiopathic pulmonary fibrosis, along with a recent acute worsening of your symptoms. Participants should be able to provide informed consent, either directly or through a family member if they are unable to do so themselves. Throughout the trial, you will receive careful monitoring, and the goal is to determine whether glucocorticoids help improve your condition compared to a placebo (a treatment that looks like the medicine but has no active ingredients). This study is currently recruiting participants, and everyone involved will be contributing to important research that could shape future treatment options for this challenging disease.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patient is ≥ 18 years of age
  • 2. IPF or IPF (likely) diagnosis defined on 2018 international recommendations
  • 3. 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".
  • 1. 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.
  • 2. If no previous computed tomography is available, the qualifier "new" can be dropped from the third criterion.
  • 4. 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)
  • 5. Affiliation to the social security
  • 6. 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
  • Exclusion Criteria:
  • 1. Identified etiology for acute worsening (i.e.: infectious disease)
  • 2. Known hypersensitivity to glucocorticoids or to any component of the study treatment
  • 3. Patient requiring mechanical ventilation or already on mechanical ventilation
  • 4. 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.
  • 5. Active cancer
  • 6. Patient on a lung transplantation waiting list
  • 7. Treatment with glucocorticoids \> 1 mg/kg/d from more than 7 days in the last 15 days
  • 8. Patient participating to another interventional clinical trial
  • 9. Documented pregnancy or lactation
  • 10. Patient under tutorship or curatorship
  • 11. Patient deprived of liberty
  • 12. Patient under court protection

About Fondation Hôpital Saint Joseph

Fondation Hôpital Saint-Joseph is a dedicated clinical trial sponsor committed to advancing healthcare and improving patient outcomes through innovative research. Located in a reputable healthcare institution, the foundation collaborates with healthcare professionals and researchers to conduct high-quality clinical trials across various medical fields. By fostering a culture of scientific excellence and patient-centered care, Fondation Hôpital Saint-Joseph aims to contribute valuable insights to the medical community and enhance the quality of treatments available to patients.

Locations

Paris, , France

Nancy, , France

Tours, , France

Angers, , France

Caen, , France

Rennes, , France

Nantes, , France

Grenoble, , France

Lille, , France

Bordeaux, , France

Toulouse, , France

Bobigny, , France

Clamart, , France

Paris, , France

Reims, , France

Strasbourg, , France

Marseille, , France

Paris, , France

Rouen, , France

Lyon, , France

Dijon, , France

Paris, , France

Besançon, , France

Paris, , France

Paris, , France

Nice, , France

Montpellier, , France

Créteil, , France

Clermont Ferrand, , France

Lille, , France

Paris, , France

Paris, , France

Patients applied

0 patients applied

Trial Officials

Jean-Marc NACCACHE

Study Director

Fondation Hôpital Saint-Joseph

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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