A Randomised, Double-blind, 8 Treatments, 4 Periods, Incomplete Crossover Study to Determine the Optimal Free Dose Combination of BI 1744 CL and Tiotropium Bromide (Both Delivered by the Respimat® Inhaler) After 4 Weeks Once Daily Treatment in Patients With COPD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 33
- 主要终点
- Trough FEV1 Response
研究概览
简要总结
The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment in patients with COPD.
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
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
olodaterol (BI 1744) low and placebo
low dose inhaled olodaterol orally once daily from the Respimat inhaler
干预措施: olodaterol (BI 1744) low (Drug)
olodaterol (BI 1744) low and placebo
low dose inhaled olodaterol orally once daily from the Respimat inhaler
干预措施: Placebo (Drug)
olodaterol (BI 1744) low and placebo
low dose inhaled olodaterol orally once daily from the Respimat inhaler
干预措施: Respimat (Device)
olodaterol (BI 1744) low and low tio
low dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: olodaterol (BI 1744) low (Drug)
olodaterol (BI 1744) low and low tio
low dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: low tiotropium bromide (Drug)
olodaterol (BI 1744) low and low tio
low dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: Respimat (Device)
olodaterol (BI 1744) low and medium tio
low dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: olodaterol (BI 1744) low (Drug)
olodaterol (BI 1744) low and medium tio
low dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: medium tiotropium bromide (Drug)
olodaterol (BI 1744) low and medium tio
low dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: Respimat (Device)
olodaterol (BI 1744) low and high tio
low dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: olodaterol (BI 1744) low (Drug)
olodaterol (BI 1744) low and high tio
low dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: high tiotropium bromide (Drug)
olodaterol (BI 1744) low and high tio
low dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: Respimat (Device)
olodaterol (BI 1744) high and placebo
high dose inhaled olodaterol orally once daily from the Respimat inhaler
干预措施: olodaterol (BI 1744) high (Drug)
olodaterol (BI 1744) high and placebo
high dose inhaled olodaterol orally once daily from the Respimat inhaler
干预措施: Placebo (Drug)
olodaterol (BI 1744) high and placebo
high dose inhaled olodaterol orally once daily from the Respimat inhaler
干预措施: Respimat (Device)
Olodaterol (BI 1744) high and low tio
high dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: low tiotropium bromide (Drug)
Olodaterol (BI 1744) high and low tio
high dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: olodaterol (BI 1744) high (Drug)
Olodaterol (BI 1744) high and low tio
high dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: Respimat (Device)
Olodaterol (BI 1744) high and medium tio
high dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: olodaterol (BI 1744) high (Drug)
Olodaterol (BI 1744) high and medium tio
high dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: medium tiotropium bromide (Drug)
Olodaterol (BI 1744) high and medium tio
high dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: Respimat (Device)
Olodaterol (BI 1744) high and high tio
high dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: olodaterol (BI 1744) high (Drug)
Olodaterol (BI 1744) high and high tio
high dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: high tiotropium bromide (Drug)
Olodaterol (BI 1744) high and high tio
high dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily
干预措施: Respimat (Device)
结局指标
主要结局
Trough FEV1 Response
时间窗: Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29
Adjusted means of the trough forced expiratory volume in one second (FEV1) response (L) after four weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
次要结局
- Trough Forced Vital Capacity (FVC) Response(Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29)
- FEV1 AUC 0-3h and FEV1 AUC 0-6h Response(Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29)
- FEV1 AUC 0-3h Response After the First Dose(Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1)
- FEV1 Peak 0-3h Response(Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29)
- FEV1 Peak 0-3h Response After the First Dose(Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1)
- FVC AUC 0-3h and FEV1 AUC 0-6h Responses(Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29)
- FVC AUC 0-3h Response After First Dose(Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on days 1)
- FVC Peak 0-3h Response(Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29)
- FVC Peak 0-3h Response After the First Dose(Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1)
- PEF AUC 0-3h and AUC 0-6h Responses(Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29)
- PEF AUC 0-3h Response After the First Dose(Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1)
- PEF Peak 0-3h Response(Baseline 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29)
- PEF Peak 0-3h Response After the First Dose(Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1)
- Individual FEV1 Measurements at Each Time Point on Day 29(Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29)
- Individual FVC Measurements at Each Time Point on Day 29(Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29)
- Individual PEF Measurements at Each Time Point on Day 29(Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29)
- Weekly Mean Number of Puffs of Rescue Medication Used Per Day(Weeks 1 and 4)
- Physicians Global Evaluation(Days 1 and 29)
- Patients Global Rating(Day 29)
- Pulse Rate Recorded in Conjunction With Spirometry(Baseline and 30 min post-dose on day 29)
- Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry(Baseline and 30 min post-dose on day 29)