Dataset from A Six Month Double Blind Randomized Placebo Controlled Trial Followed by Each Arm Being Converted to Oral Nintedanib 150 mg Twice Daily Comparing the Effect on High Resolution Computerized Tomography Quantitative Lung Fibrosis Score, Lung Function, Six Minute Walk Test Distance and St. George's Respiratory Questionnaire After Six Months of Treatment in Patients With Idiopathic Pulmonary Fibrosis With Continued Evaluations Over a Period of up to Eighteen Months

This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind clinical trial followed by conversion of each arm to active nintedanib for an additional 6 months comparing the effect of nintedanib 150mg bis in die (BID twice daily) on the progression of IPF measured by using High Resolution Computerized Tomography(HRCT), lung function, functional component (6MWT), biomarkers, and PRO component (PROs) with continued treatment and assessments for up to 18 months.

本研究为一项为期6个月的多中心、前瞻性、随机、安慰剂对照双盲临床试验，随后将所有试验分组的受试者均转为接受活性药物尼达尼布（nintedanib）治疗，额外开展6个月的随访。本试验对比每日两次（bis in die，缩写BID）口服150mg尼达尼布与安慰剂对特发性肺纤维化（Idiopathic Pulmonary Fibrosis, IPF）进展的影响，评估指标涵盖高分辨率计算机断层扫描（High Resolution Computerized Tomography, HRCT）影像、肺功能、6分钟步行试验（6-Minute Walk Test, 6MWT）功能学指标、生物标志物以及患者报告结局（Patient-Reported Outcomes, PROs），整个研究的持续治疗与评估周期最长可达18个月。