INSTAGE: A 24-week, Double-blind, Randomized, Parallel-group Study Evaluating the Efficacy and Safety of Oral Nintedanib Co-administered With Oral Sildenafil, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Advanced Lung Function Impairment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 85
- 主要终点
- Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score at Week 12
研究概览
简要总结
To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.
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 (Participant, Investigator)
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 + placebo matching sildenafil
干预措施: Nintedanib (Drug)
Nintedanib + placebo matching sildenafil
干预措施: Placebo (Drug)
Nintedanib + Sildenafil
干预措施: Nintedanib (Drug)
Nintedanib + Sildenafil
干预措施: Sildenafil (Drug)
结局指标
主要结局
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score at Week 12
时间窗: Baseline and week 12
The SGRQ is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. Scores range from 0 to 100, with higher scores indicating more limitations. The mean and standard error presented are actually adjusted mean for change from baseline and its standard error.
次要结局
- Change From Baseline in Dyspnoea Using UCSD SOBQ at Week 24(Baseline and week 24)
- Change From Baseline in Dyspnoea Using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) at Week 12(Baseline and week 12)
- Percentage of Patients With On-treatment Serious Adverse Events (SAE) From Baseline to Week 24(Baseline and week 24)
- Change From Baseline in SGRQ Total Score at Week 24(Baseline and week 24)