PF-ILD试验设计：一项针对进行性纤维化间质性肺病患者的尼达尼布双盲、随机、安慰剂对照III期试验。
Design of the PF-ILD trial: a double-blind, randomised, placebo-controlled phase III trial of nintedanib in patients with progressive fibrosing interstitial lung disease.
作者信息
Flaherty Kevin R, Brown Kevin K, Wells Athol U, Clerisme-Beaty Emmanuelle, Collard Harold R, Cottin Vincent, Devaraj Anand, Inoue Yoshikazu, Le Maulf Florence, Richeldi Luca, Schmidt Hendrik, Walsh Simon, Mezzanotte William, Schlenker-Herceg Rozsa
机构信息
Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, Michigan, USA.
Department of Medicine, National Jewish Health, Denver, Colorado, USA.
出版信息
BMJ Open Respir Res. 2017 Sep 17;4(1):e000212. doi: 10.1136/bmjresp-2017-000212. eCollection 2017.
UNLABELLED
600 patients aged ≥18 years will be randomised in a 1:1 ratio to nintedanib or placebo. Patients with diagnosis of IPF will be excluded. The study population will be enriched with two-thirds having a usual interstitial pneumonia-like pattern on HRCT. The primary endpoint is the annual rate of decline in forced vital capacity over 52 weeks. The main secondary endpoints are the absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire total score, time to first acute interstitial lung disease exacerbation or death and time to all-cause mortality over 52 weeks.
ETHICS AND DISSEMINATION
The trial is conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (GCP) and Japanese GCP regulations.
TRIAL REGISTRATION NUMBER
NCT02999178.
未标注
600名年龄≥18岁的患者将按1:1比例随机分为尼达尼布组或安慰剂组。诊断为特发性肺纤维化（IPF）的患者将被排除。研究人群将有三分之二在高分辨率计算机断层扫描（HRCT）上呈现出普通间质性肺炎样模式。主要终点是52周内用力肺活量的年下降率。主要次要终点是国王间质性肺病简短问卷总分相对于基线的绝对变化、首次急性间质性肺病加重或死亡的时间以及52周内全因死亡率的时间。
伦理与传播
该试验按照《赫尔辛基宣言》、国际协调会议三方良好临床实践指南（GCP）和日本GCP法规进行。
试验注册号
NCT02999178。
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