A Randomised, Double-blind, Cross-over Study to Evaluate the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (5/5 µg) Compared With Tiotropium (5 µg), Both Delivered by the Respimat® Inhaler, on Breathlessness During the Three Minute Constant Speed Shuttle Test (3min CSST) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [OTIVATO TM]
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 13
- 主要终点
- Change From Baseline in Intensity of Breathlessness Measured Using the Modified Borg Scale at the End of the 3 Minute (Min) Constant Speed Shuttle Test After 6 Weeks of Treatment.
研究概览
简要总结
The primary objective of the present study is to evaluate the effect of tiotropium + olodaterol fixed dose combination (FDC) compared to tiotropium monotherapy on the intensity of breathlessness during the 3min constant speed shuttle test (CSST).
A secondary objective is to explore the relationship between reductions in breathlessness during the 3min CSST and reductions in breathlessness during activities of everyday living as measured by the dyspnea domain of the Chronic Respiratory Questionnaire (CRQ) following bronchodilator therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tiotropium + Olodaterol
Patients will receive tiotropium 5mcg + olodaterol 5mcg in a fixed dose combination once daily.
干预措施: Tiotropium (Drug)
Tiotropium + Olodaterol
Patients will receive tiotropium 5mcg + olodaterol 5mcg in a fixed dose combination once daily.
干预措施: Olodaterol (Drug)
Tiotropium
干预措施: Tiotropium (Drug)
结局指标
主要结局
Change From Baseline in Intensity of Breathlessness Measured Using the Modified Borg Scale at the End of the 3 Minute (Min) Constant Speed Shuttle Test After 6 Weeks of Treatment.
时间窗: Baseline and week 6
At 3 min or end of exercise (if 3 min not achieved), patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). The modified Borg scale is 10-point subjective scoring system, in which a patient rates effort of exertion while performing a particular activity. The scale is 0 to 10, the higher the score, the greater the perceived difficulty. Measure type is actually Adjusted Mean Change from Baseline.
次要结局
- Change From Baseline After 6 Weeks of Treatment for 1 Hour Post-dose Forced Expiratory Volume(Baseline and week 6)
- Change From Baseline After 6 Weeks of Treatment for Intensity of Breathlessness (MBS-S) at 1, 2 and 2.5 Minute (Min) During the 3 Min Constant Speed Shuttle Test(Baseline and week 6)
- Change From Baseline After 6 Weeks of Treatment for Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS) Dyspnoea Domain Score(Baseline and week 6)
- Change From Baseline After 6 Weeks of Treatment for Inspiratory Capacity Measured Prior to Exercise(Baseline and week 6)
- Change From Baseline After 6 Weeks of Treatment for Inspiratory Capacity Measured at the End of Exercise(Baseline and week 6)
- Change From Baseline After 6 Weeks of Treatment for 1 Hour Post-dose Forced Vital Capacity(Baseline and week 6)
- Change From Baseline After 6 Weeks of Treatment for Chronic Respiratory Questionnaire - Self Administered Individualized (CRQ-SAI) Dyspnoea Domain Score(Baseline and week 6)