跳至主要内容
临床试验/NCT01525615
NCT01525615已完成3 期

A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg and 5/5 µg) Delivered by the Respimat® Inhaler, on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD)[Torracto (TM)]

Boehringer Ingelheim60 个研究点 分布在 9 个国家目标入组 404 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
404
试验地点
60
主要终点
Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks

研究概览

简要总结

The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

tiotropium+olodaterol low dose

Experimental

once daily 2 puffs, fixed dose combination (FDC) solution for inhalation Respimat

干预措施: Respimat inhaler (Device)

tiotropium+olodaterol low dose

Experimental

once daily 2 puffs, fixed dose combination (FDC) solution for inhalation Respimat

干预措施: tiotropium+olodaterol (low dose) (Drug)

tiotropium+olodaterol high dose

Experimental

once daily 2 puffs, FDC solution for inhalation Respimat

干预措施: tiotropium + olodaterol (high dose) (Drug)

tiotropium+olodaterol high dose

Experimental

once daily 2 puffs, FDC solution for inhalation Respimat

干预措施: Respimat inhaler (Device)

placebo

Placebo Comparator

once daily 2 puffs, solution for inhalation Respimat

干预措施: Respimat inhaler (Device)

placebo

Placebo Comparator

once daily 2 puffs, solution for inhalation Respimat

干预措施: placebo to tiotropium+olodaterol (Drug)

结局指标

主要结局

Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks

时间窗: 12 weeks

Primary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.

次要结局

  • Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks(6 weeks)
  • Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 6(6 weeks)
  • Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 6 Weeks(6 weeks)
  • Adjusted Mean Inspiratory Capacity at Pre-exercise After 12 Weeks(12 weeks)
  • Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) on Day 1(1 day)
  • Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 6 Weeks Treatment(6 weeks)
  • Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 12(12 weeks)
  • Adjusted Mean Endurance Time During Endurance Shuttle Walk Test (ESWT) After 12 Weeks(12 weeks)
  • Adjusted Mean Inspiratory Capacity at Pre-exercise After 1 Day(1 day)
  • Adjusted Mean Slope of the Intensity of Breathing Discomfort on Day 1(1 day)
  • Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) on Day 1(1 day)
  • Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 12 Weeks(12 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (60)

Loading locations...

相似试验

A Study to Determine the Effect of Tiotropium +... | 临床试验