Randomised, Double-Blind, Placebo-Controlled, 5-Way Cross-Over Study to Assess the Efficacy (Bronchoprotection) and Safety of a Single Dose of Orally Inhaled BI 1744 CL (2, 5, 10 and 20ug) in Patients With Intermittent Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours
研究概览
简要总结
The primary objective of this study is to assess the efficacy (bronchoprotection) and safety of single doses of BI 1744 CL inhalation solution (2, 5, 10 and 20 mcg) delivered via the Respimat® inhaler, in patients with intermittent asthma.
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 —（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 (BI1744) Low
Single dosing of low dose Olodaterol inhaled orally from Respimat Device
干预措施: Olodaterol (BI1744CL) (Drug)
Olodaterol (BI1744) Medium Low
Single dosing of medium low dose Olodaterol inhaled orally from Respimat Device
干预措施: Olodaterol (BI1744CL) (Drug)
Olodaterol (BI1744) Medium High
Single dosing of medium high dose Olodaterol inhaled orally from Respimat Device
干预措施: Olodaterol (BI1744CL) (Drug)
Olodaterol (BI 1744) High
Single dosing of high dose Olodaterol inhaled orally from Respimat Device
干预措施: Olodaterol (BI1744CL) (Drug)
Placebo
Single dosing of Olodaterol placebo inhaled orally from Respimat Device
干预措施: Placebo (Drug)
结局指标
主要结局
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours
时间窗: 24 hours post dose
Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours
次要结局
- Laboratory Testing: Average Change From Baseline of Potassium and Calcium(Baseline to Visit 6)
- Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes(30 minutes post dose)
- Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours(4 hours post dose)
- Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours(8 hours post dose)
- Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours(32 hours post dose)
- Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG(5 days)