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.

Authors

Keisuke Anan, Yuki Kataoka, Masataka Taguri, Kazuya Ichikado, Ryo Tachikawa, Kazunori Tobino, Kodai Kawamura, Chigusa Shirakawa, Takafumi Kawabata, Yosuke Yamamoto

Published in

BMJ open respiratory research. Volume 13. Issue 1. Jun 28, 2026. Epub Jun 28, 2026.

Abstract

Acute 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.
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.
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.
Japan Registry of Clinical Trials (jRCT1071250015).

PMID:
42373123
Bibliographic data and abstract were imported from PubMed on 30 Jun 2026.

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