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

Korábbi kezelés

• Patient on a lung transplantation waiting list
• Treatment with glucocorticoids > 1 mg/kg/d from more than 7 days in the last 15 days

Más betegség

• 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

Egyéb

• 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

• 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