A Randomised, Double-Blind, Placebo- and Active-Controlled, Incomplete Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Once Daily Treatment of 4 Doses of BI 1744 CL Inhalation Solution Delivered by the Respimat® in Patients With Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 27
- 主要终点
- Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period
研究概览
简要总结
The primary objective of this study is to determine the efficacy and safety of 4 doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with asthma in comparison to placebo.
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 70 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 (BI 1744) low
Low dose inhaled orally once daily from the Respimat inhaler
干预措施: Olodaterol (BI 1744) low (Drug)
Olodaterol (BI 1744) very low
Very low dose inhaled orally once daily from the Respimat inhaler
干预措施: Olodaterol (BI 1744) very low (Drug)
Olodaterol (BI 1744) medium
Medium dose inhaled orally once daily from the Respimat inhaler
干预措施: Olodaterol (BI 1744) medium (Drug)
Olodaterol (BI 1744) high
High dose inhaled orally once daily from the Respimat inhaler
干预措施: Olodaterol (BI 1744) high (Drug)
Formoterol 12 mcg
12mcg inhaled twice daily from the Aerolizer inhaler
干预措施: Formoterol 12 mcg (Drug)
Placebo
Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler and/or Formoterol placebo inhaled twice daily from the Aerolizer inhaler
干预措施: Placebo (Drug)
结局指标
主要结局
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period
时间窗: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.
次要结局
- FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response at the End of Each Treatment Period(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks)
- FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response at the End of Each Treatment Period(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks)
- Peak FEV1 Within 24 Hours Post-dose Response(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks)
- Trough FEV1 Response(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks)
- Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h , 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks)
- Peak FVC Within 24 Hours Post-dose Response(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks)
- Trough FVC Response(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks)
- Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks)
- PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks)
- Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks)
- FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks)
- FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 min, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks)
- Peak PEF Within 24 Hours Post-dose Response(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks)
- Trough PEF Response(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks)
- Mean Pre-dose Morning PEF (PEF a.m.)(2-4 weeks)
- Mean Pre-dose Evening PEF (PEF p.m.)(2-4 weeks)
- PEF Daily Variability(2-4 weeks)
- Mean Pre-dose Morning FEV1 (FEV1 a.m.)(2-4 weeks)
- Mean Pre-dose Evening FEV1 (FEV1 p.m.)(2-4 weeks)
- Mean Number of Puffs of Rescue Medication During the Whole Day(2-4 weeks)
- Percentage of Asthma Symptom Free Days(2-4 weeks)
- Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)(2-4 weeks)
- Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)(2-4 weeks)
- Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)(2-4 weeks)
- Total Asthma Quality of Life Questionnaire (AQLQ(s)) Score(4 weeks)
- Total Asthma Control Questionnaire (ACQ) Score(4 weeks)
- Potassium 1 Hour Pre-dose(4 weeks)
- Potassium 1 Hour Post-dose(4 weeks)
- Potassium 3 Hours Post-dose(4 weeks)
- Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG(4 weeks)