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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU ANgers
  Angers, France Recruiting
• CHU de Besancon
  Besançon, France Recruiting
• CHU BOrdeaux
  Bordeaux, France Recruiting
• CHU Caen
  Caen, France Recruiting
• Chic
  Créteil, France Recruiting
• CHU de Dijon
  Dijon, France Recruiting

Study contacts

• Study coordinator: Jean-Marc NACCACHE, MD
• Email: jmnaccache@ghpsj.fr
• Phone: 144126747

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• IVIG for sudden severe flare-ups of idiopathic pulmonary fibrosis

  This trial will try adding intravenous immunoglobulin (IVIG) to standard hospital care to see if it helps people hospitalized with sudden, severe worsening of idiopathic pulmonary fibrosis.

  Recruiting Phase 3 University General Hospital of Patras · Pátrai · NCT07299695

• Inflammation, infection and treatments during severe cystic fibrosis flare-ups

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• Causes and risk factors of lung exacerbations in cystic fibrosis

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  Recruiting at 8 sites University of Manchester · Manchester, Manchester and 17 other locations · NCT06940531

• Comparing antibiotic treatments for lung issues in cystic fibrosis

  This study is testing whether a combination of two types of antibiotics can help people with cystic fibrosis recover better from lung problems than using just one type of antibiotic.

  Recruiting at 59 sites Phase 4 Seattle Children's Hospital · Birmingham, Alabama and 59 other locations · NCT05548283

• New IPF drug ORJ-001 tested in adults with IPF

  A phase 2 study tests ORJ-001 versus placebo in adults with idiopathic pulmonary fibrosis to see if it is tolerated and whether it helps lung function.

  Recruiting at 2 sites Phase 2 Oorja Bio, Inc. · Doral, Florida and 1 other locations · NCT07869147

• Nalbuphine ER for IPF-related chronic cough

  This study tests whether extended-release nalbuphine tablets can reduce chronic cough in people with idiopathic pulmonary fibrosis.

  Recruiting at 4 sites Phase 3 Trevi Therapeutics · Wilmington, Delaware and 3 other locations · NCT07868419

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.