Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis (EXAFIP2)
Acute Exacerbation of Idiopathic Pulmonary Fibrosis
About this trial
This is an interventional treatment trial for Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Identified etiology for acute worsening (i.e.: infectious disease) Known hypersensitivity to glucocorticoids or to any component of the study treatment Patient requiring mechanical ventilation or already on mechanical ventilation 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 on a lung transplantation waiting list Treatment with glucocorticoids > 1 mg/kg/d from more than 7 days in the last 15 days Patient participating to another interventional clinical trial Documented pregnancy or lactation Patient under tutorship or curatorship Patient deprived of liberty Patient under court protection
Sites / Locations
- CHU ANgers
- CHU de Besancon
- Hôpital Avicenne
- CHU BOrdeaux
- CHU Caen
- CHU Clermont-Ferrand
- CHIC
- CHU de Dijon
- CHU Grenoble
- CHRU Lille
- Hospices Civils de Lyon
- Hôpital Nord
- CHU de Montpellier
- CHU Nancy
- CHU de Nantes
- CHU Nice
- Groupe Hospitalier Paris Saint-Joseph
- Hôpital Bichat
- Hôpital Européen Georges Pompidou
- Hôpital FOCH
- Hôpital Kremiln Bicetre
- Hôpital Saint-Louis
- Hôpital Tenon
- CHU Reims
- CHU Rennes
- CHU Rouen
- CHU Strasbourg
- CHU Toulouse
- CHU Tours
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
MethylPrednisone/Prednisone
Placebo
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.
Day 1, 2 and 3: Intravenous Methylprednisolone-Placebo From Day 4 to Day 30: Oral Prednisone-Placebo