NCT03717012终止4 期
Study of Pulmonary Rehabilitation In Nintedanib Treated Patients With IPF: Improvements in Activity, Exercise Endurance Time, and QoL
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 19
- 主要终点
- Change From Baseline in the 6 Minute Walk Test (6MWD) at 12 Weeks
研究概览
简要总结
The main objectives of this study are:
- Determine the difference in change from baseline in Six Minute Walk Distance (6MWD) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF)
- Determine the difference in change in Quality of Life (QoL) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF)
- Determine if there is an enduring effect in 6MWD, QoL and lung function from pulmonary rehabilitation (PR) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF)
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
- None
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 treatment alone
Active Comparator
干预措施: Nintedanib (Drug)
Nintedanib with a pulmonary rehabilitation program
Experimental
干预措施: Nintedanib (Drug)
Nintedanib with a pulmonary rehabilitation program
Experimental
干预措施: Pulmonary rehabilitation program (Other)
结局指标
主要结局
Change From Baseline in the 6 Minute Walk Test (6MWD) at 12 Weeks
时间窗: Baseline (day 1) and week 12 (day 85).
Absolute change from baseline in the 6 minute walk distance (6MWD) test at 12 weeks. The last assessment before treatment period start (included) will be used as baseline. If the baseline value is missing and the screening value is available, then the baseline value will be defined as the screening value taken closest to baseline date.
次要结局
- Change From Baseline in the St George's Respiratory Questionnaire (SGRQ) Total Score at 12 and 24 Weeks(Baseline (day 1), week 12 (day 85) and week 24 (day 169).)
- Absolute Change From Baseline in The King's Brief Interstitial Lung Disease (KBILD) Questionnaire Total Score at 12 and 24 Weeks(Baseline (day 1), week 12 (day 85) and week 24 (day 169).)
- Change From Baseline in the University of California, San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) Total Score at 12 and 24 Weeks(Baseline (day 1), week 12 (day 85) and week 24 (day 169).)
- Absolute Change From Baseline of Forced Vital Capacity (FVC) at 12 and 24 Weeks(Baseline (day 1), week 12 (day 85) and week 24 (day 169).)
- Change From Baseline in the 6 Minute Walk Test (6MWD) at 24 Weeks(Baseline (day 1) and week 24 (day 169).)
- Relative Change From Baseline of Forced Vital Capacity (FVC) at 12 and 24 Weeks(Baseline (day 1), week 12 (day 85) and week 24 (day 169).)
- Absolute Change From Baseline of Forced Vital Capacity (FVC) % Predicted at 12 and 24 Weeks(Baseline (day 1), week 12 (day 85) and week 24 (day 169).)
- Relative Change From Baseline of Forced Vital Capacity (FVC) % Predicted at 12 and 24 Weeks(Baseline (day 1), week 12 (day 85) and week 24 (day 169).)
- Change From Baseline in Daily Accelerometer Activity From Baseline at 12 and 24 Weeks: Score of Average Vector Magnitude Units (VMU)/Day(Baseline (day 1), week 12 (day 85) and week 24 (day 169).)
- Absolute Categorical Change of Forced Vital Capacity (FVC)% Predicted up to 12 and 24 Weeks (Decrease by >5%, Increase by >5%, and Change Within ≤5%)(Baseline (day 1), week 12 (day 85) and week 24 (day 169).)
- Absolute Categorical Change of Forced Vital Capacity (FVC)% Predicted up to 12 and 24 Weeks (Decrease by >10%, Increase by >10%, and Change Within ≤10%)(Baseline (day 1), week 12 (day 85) and week 24 (day 169).)
- Change From Baseline in Daily Accelerometer Activity From Baseline at 12 and 24 Weeks: Score of Average Steps/Day(Baseline (day 1), week 12 (day 85) and week 24 (day 169).)
研究者
研究点 (19)
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