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

Study acronym: EXAFIP2
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 2, 2026 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Oct 25, 2025 to Mar 30, 2026v9
  2. Re-verified, no change to tracked fieldsv8
  3. Site details revised at 3 of 29 sitesv7
  4. Site details revised at 13 of 29 sitesv6
  5. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Sep 14, 2025 to Oct 25, 2025
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Start date changed from estimate of Sep 15, 2023 to Oct 26, 2023
    • Study sites revised (29)
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites revised (29)v4
  2. Primary completion date: Mar 14, 2025 to Sep 14, 2025
    • Start date: Mar 15, 2023 to Sep 15, 2023
    v3
  3. Phase: Phase 2 to Phase 3
    • Eligibility criteria expanded, about 125 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05674994
Lead Sponsor Fondation Hôpital Saint-Joseph
Conditions
(from sponsor)		 Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov