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Comparing glucocorticoids to placebo for treating acute exacerbations of idiopathic pulmonary fibrosis

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

Phase 3 Interventional Fondation Hôpital Saint-Joseph · NCT05674994

This study is testing if glucocorticoids like methylprednisone and prednisone can help people with acute flare-ups of idiopathic pulmonary fibrosis feel better compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment110 (estimated)
Ages18 Years and up
SexAll
SponsorFondation Hôpital Saint-Joseph Academic / other
Drugs / interventionsrituximab, cyclophosphamide, prednisone
Locations29 sites (Angers and 28 other locations)
Trial IDNCT05674994 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of glucocorticoids, specifically methylprednisone and prednisone, compared to a placebo in patients experiencing acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF). Given the high mortality rate associated with AE-IPF, the study seeks to confirm whether glucocorticoids can improve patient outcomes and to identify any potential harmful effects. The trial will involve patients who meet specific diagnostic criteria for AE-IPF, ensuring a standardized approach to treatment evaluation. By addressing a critical gap in current treatment options, this study could provide valuable insights into managing this severe condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with idiopathic pulmonary fibrosis who are experiencing an acute exacerbation.

Not a fit: Patients with alternative diagnoses for their acute worsening or those who do not meet the specific diagnostic criteria for acute exacerbation of idiopathic pulmonary fibrosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a validated treatment option that significantly improves survival rates for patients with acute exacerbations of idiopathic pulmonary fibrosis.

How similar studies have performed: While previous studies have explored various treatments for acute exacerbations of idiopathic pulmonary fibrosis, this specific approach using glucocorticoids has not been conclusively validated, making it a novel investigation.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Angers and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.