Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondation Hôpital Saint-Joseph
About this trial
Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is associated with a poor prognosis, with a 3-month mortality rate of over 50%. To date, no treatment has been proven to be effective in AI-FPI. The interest of glucocorticoids is controversial and needs to be confirmed. This confirmation is mandatory to validate the improvement of the prognosis of EA-IPF under this treatment but also to search for unsuspected deleterious effects as it has been shown with immunosuppressants in stable idiopathic pulmonary fibrosis.
Eligibility criteria
Qualifiers
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
Previous or concurrent diagnosis of IPF (a)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Methylprednisone/Prednisone
- Placebo
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov