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临床试验/NCT02085161
NCT02085161已完成3 期

An Exploratory, 12 Week, Randomised, Partially Double-blinded, Placebo-controlled Parallel Group Trial to Explore the Effects of Once Daily Treatments of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination or Tiotropium (Both Delivered by Respimat® Inhaler), Supervised Exercise Training and Behavior Modification on Exercise Capacity and Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim1 个研究点 分布在 1 个国家目标入组 304 人开始时间: 2014年3月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
304
试验地点
1
主要终点
Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks

研究概览

简要总结

The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity 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
Single

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

placebo

Placebo Comparator

patient will receive placebo once daily, 2 puffs in the morning

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

tiotropium + olodaterol high dose with BM

Experimental

patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning

干预措施: tiotropium +olodaterol (Drug)

tiotropium

Active Comparator

patient will receive tiotropium 5 mcg once daily, 2 puffs in the morning

干预措施: tiotropium (Drug)

tiotropium + olodaterol with exercise training and BM

Experimental

patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning

干预措施: tiotropium+olodaterol (Drug)

结局指标

主要结局

Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks

时间窗: Week 8

Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 8 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then an analysis of covariance (ANCOVA) was fitted to the log10-transformed data and the least square means (LSMean) and standard error (SE) were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.

次要结局

  • Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 12(Week 12)
  • Average Daily Walking Intensity Measured by the Activity Monitor in the Week Prior to 12 Weeks of Treatment(Week 12)
  • Perceived Difficulties as Evaluated With Functional Performance Inventory-Short Form (FPI-SF) Total Score at Week 12(Week 12)
  • Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 12 Weeks(Week 12)
  • One Hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 8 Weeks of Treatment(Week 8)
  • One Hour, Post-dose Forced Vital Capacity (FVC) After 8 Weeks of Treatment(Week 8)
  • Resting Inspiratory Capacity (IC) Measured at 1.5 Hours Post Dose After 8 Weeks of Treatment(Week 8)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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