ArticleBMJ open respiratory research2026
Efficacy and safety of RApid PrednIsolone Dose reduction for acute exacerbation of Idiopathic Pulmonary Fibrosis (RAPID-IPF Trial): a study protocol for a randomised controlled trial.
Article in BMJ open respiratory research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionAcute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a life-threatening event with high mortality. While systemic corticosteroids are commonly used in clinical practice for AE-IPF despite the absence of randomised evidence, the optimal tapering strategy is uncertain. Early corticosteroid tapering reduces adverse events in other inflammatory diseases. However, the efficacy and safety of this approach in AE-IPF have not been established. This study aims to determine if an early corticosteroid tapering regimen is non-inferior to a conventional regimen for 90-day mortality in patients with AE-IPF. METHODS AND ANALYSIS: The RApid PrednIsolone Dose reduction for acute exacerbation of Idiopathic Pulmonary Fibrosis (RAPID-IPF) trial is a multicentre, parallel-group, open-label, randomised controlled non-inferiority trial conducted in Japan. A total of 70 patients (up to 130) hospitalised for AE-IPF will be randomly assigned in a 1:1 ratio to either an accelerated 6-week prednisolone tapering regimen (early tapering group) or a conventional 12-week tapering regimen (standard tapering group). The primary outcome is all-cause mortality at 90 days. The non-inferiority margin is set at a 10% risk difference. Key secondary outcomes include 28-day mortality, mortality due to respiratory causes, time to respiratory worsening or death, protocol adherence and the proportion of patients lost to follow-up. The trial incorporates two interim analyses for feasibility and sample size re-estimation. ETHICS AND DISSEMINATION: This study will be conducted in compliance with the Declaration of Helsinki and Japanese ethical guidelines. The protocol was approved by the institutional review boards of all participating hospitals (lead approval: Saiseikai Kumamoto Hospital, #1367). Written informed consent will be obtained from all participants or their legally acceptable representatives. Findings will be disseminated through scientific conferences and publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: Japan Registry of Clinical Trials (jRCT1071250015).
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