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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 25
- 主要终点
- Relative Change From Baseline in High Resolution Computerized Tomography (HRCT) Quantitative Lung Fibrosis (QLF) Score at 6 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nintedanib
150 mg twice daily
干预措施: Nintedanib (Drug)
Placebo
twice daily dosing
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Relative Change From Baseline in High Resolution Computerized Tomography (HRCT) Quantitative Lung Fibrosis (QLF) Score at 6 Months
时间窗: Baseline and 6 Months
Relative change from baseline in HRCT QLF score at 6 months was calculated as the difference of the QLF score at month 6 minus the QLF score at baseline divided by the baseline QLF score. The QLF score itself ranges from 0 to 100%, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. Hence smaller relative changes from baseline (i.e., ratios) were considered favorable. HCRT assessment obtained during screening visit was considered as baseline.
次要结局
- Effect of Six Month Delayed Treatment Onset: Relative Change From Baseline in HRCT QLF Score at 12 Months(Baseline and 12 Months)
- St. George's Respiratory Questionnaire (SGRQ) Total Score Change From Baseline at 6 Months(Baseline and 6 Months)
- Absolute Change in Forced Vital Capacity (FVC) From Baseline at 6 Months(Baseline and 6 Months)
- 6MWT Total Distance Walked Change From Baseline at 6 Months(Baseline and 6 Months)
- Relative Change in FVC From Baseline at 6 Months(Baseline and 6 Months)
- Categorical Change in FVC From Baseline at 6 Months(Baseline and 6 Months)
- Respiratory Hospitalizations at 6 Months(6 Months)
- Respiratory Mortality at 6 Months(6 Months)
- University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) Change From Baseline at 6 Months(Baseline and 6 Months)
- All-cause Mortality at 6 Months(6 Months)
- Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbations at 6 Months(6 Months)