Single Dose Comparison of 3 Doses of Olodaterol in Double Fixed Dose Combination With BI54903 vs. 3 Doses of Olodaterol Mono in Free Combination
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- FEV1 (AUC0-12h) FEV1 = Forced expiratory volume in one second, AUC = area under the curve
研究概览
简要总结
The aim of the study is to establish the olodaterol dose in the ethanolic fixed dose combination (FDC) with BI 54903 which is equivalent in bronchodilator effect and systemic exposure to the 5 µg olodaterol reference dose in the aqueous inhalation solution (AIS).
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
- 18 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
Olodaterol medium dose + BI54903
patient to receive 2 puffs of each device
干预措施: BI54903 (Drug)
Olodaterol m dose + BI54903
patient to receive 2 puffs of each device
干预措施: BI54903 (Drug)
Olodaterol h dose + BI54903
patient to receive 2 puffs of each device
干预措施: BI54903 (Drug)
Olodaterol m dose + BI54903
patient to receive 2 puffs of each device
干预措施: Olodaterol & BI54903 (Drug)
Olodaterol m dose + BI54903
patient to receive 2 puffs of each device
干预措施: Respimat (Device)
Olodaterol h dose + BI54903
patient to receive 2 puffs of each device
干预措施: Respimat (Device)
Placebo + BI 54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
干预措施: Respimat (Device)
Olodaterol low dose + BI54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
干预措施: Respimat (Device)
Placebo + BI 54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
干预措施: BI54903 (Drug)
Olodaterol medium dose + BI54903
patient to receive 2 puffs of each device
干预措施: Respimat (Device)
Olodaterol high dose + BI54903
patient to receive 2 puffs of each device
干预措施: Respimat (Device)
Olodaterol high dose + BI54903
patient to receive 2 puffs of each device
干预措施: BI54903 (Drug)
Olodaterol high dose + BI54903
patient to receive 2 puffs of each device
干预措施: Olodaterol & BI54903 (Drug)
Olodaterol l dose + BI54903
patient to receive 2 puffs of each device
干预措施: Respimat (Device)
Olodaterol h dose + BI54903
patient to receive 2 puffs of each device
干预措施: Olodaterol & BI54903 (Drug)
Placebo + BI 54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
干预措施: Olodaterol & BI54903 (Drug)
Olodaterol low dose + BI54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
干预措施: Olodaterol & BI54903 (Drug)
Olodaterol low dose + BI54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
干预措施: BI54903 (Drug)
Olodaterol l dose + BI54903
patient to receive 2 puffs of each device
干预措施: BI54903 (Drug)
Olodaterol l dose + BI54903
patient to receive 2 puffs of each device
干预措施: Olodaterol & BI54903 (Drug)
Olodaterol medium dose + BI54903
patient to receive 2 puffs of each device
干预措施: Olodaterol & BI54903 (Drug)
Placebo + BI 54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
干预措施: Olodaterol (Drug)
Olodaterol low dose + BI54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
干预措施: Olodaterol (Drug)
Olodaterol medium dose + BI54903
patient to receive 2 puffs of each device
干预措施: Olodaterol (Drug)
Olodaterol high dose + BI54903
patient to receive 2 puffs of each device
干预措施: Olodaterol (Drug)
Olodaterol l dose + BI54903
patient to receive 2 puffs of each device
干预措施: Olodaterol (Drug)
Olodaterol m dose + BI54903
patient to receive 2 puffs of each device
干预措施: Olodaterol (Drug)
Olodaterol h dose + BI54903
patient to receive 2 puffs of each device
干预措施: Olodaterol (Drug)
结局指标
主要结局
FEV1 (AUC0-12h) FEV1 = Forced expiratory volume in one second, AUC = area under the curve
时间窗: 12 hours
次要结局
- FEV1 (AUC0-24h)(24 hours)
- FEV1 (AUC12-24h)(12 hours)
- Peak FEV1(12 hours)