Dataset from A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nintedanib Over 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

The aim of the current study is to investigate the efficacy and safety of nintedanib over 52
weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as
patients who present with features of diffuse fibrosing lung disease of >10% extent on
high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms
or chest imaging have worsened despite treatment with unapproved medications used in clinical
practice to treat ILD. There is currently no efficacious treatment available for PF-ILD.
Based on its efficacy and safety in Idiopathic Pulmonary Fibrosis (IPF), it is anticipated
that Nintedanib will be a new treatment option for patients with PF-ILD.

本研究旨在评估尼达尼布（nintedanib）在进行性纤维化性间质性肺疾病（Progressive Fibrosing Interstitial Lung Disease, PF-ILD）患者中为期52周的疗效与安全性。PF-ILD的定义为：经高分辨率计算机断层扫描（HRCT）证实存在弥漫性纤维化性肺病变且病变范围＞10%，且尽管接受了临床中用于治疗间质性肺疾病（ILD）的未获批药物治疗，其肺功能、呼吸道症状或胸部影像学仍出现恶化的患者。目前PF-ILD尚无有效的治疗手段。基于尼达尼布在特发性肺纤维化（Idiopathic Pulmonary Fibrosis, IPF）中的疗效与安全性，预计其将成为PF-ILD患者的全新治疗选择。