A Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess and Compare Efficacy and Safety of a 12-week Treatment With BI 54903 at Doses of 181.8 Mcg b.i.d. and 363.6 Mcg q.d. (p.m. Dosing) Administered Via Respimat® Inhaler in Patients With Asthma Inadequately Controlled on Low Dose ICS Therapy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Mean change from randomisation baseline to the end of the 12-week treatment period in evening trough (pre-dose and pre-rescue bronchodilator) FEV1
研究概览
简要总结
The aim of this study is to assess and compare efficacy and safety of BI 54903 at medium doses twice daily and high doses once daily (evening dosing) and placebo over an 12-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on low dose inhaled corticosteroid (ICS) therapy as demonstrated by a decrease in Forced Expiratory Volume in one second (FEV1) (not less than 10 %, and equal to or less than 25%) and an Asthma Control Questionnaire (ACQ)-6 score of not less than 1.5 at time of randomisation.
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
- Double
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, 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
BI 54903 HD q.d.
Patients receive 2 puffs BI 54903 HD q.d. via Respimat inhaler (p.m.) combined with 2 puffs placebo (a.m.)
干预措施: Placebo matching Respimat (Drug)
BI 54903 HD q.d.
Patients receive 2 puffs BI 54903 HD q.d. via Respimat inhaler (p.m.) combined with 2 puffs placebo (a.m.)
干预措施: BI 54903 HD (Drug)
Placebo
Patients receive 2 puffs Placebo b.i.d. via Respimat inhaler
干预措施: Placebo matching Respimat (Drug)
BI 54903 MD b.i.d.
Patients receive 2 puffs BI 54903 MD b.i.d.via Respimat inhaler
干预措施: BI 54903 MD (Drug)
结局指标
主要结局
Mean change from randomisation baseline to the end of the 12-week treatment period in evening trough (pre-dose and pre-rescue bronchodilator) FEV1
时间窗: 12 weeks
次要结局
- Mean change from randomisation baseline to the end of the 12-week treatment period in morning and evening trough (pre-dose and pre-rescue bronchodilator) Forced Vital Capacity (FVC)(12 weeks)
- Mean change from randomisation baseline in morning and evening trough (pre-dose and pre-rescue bronchodilator) FEV1 and FVC after 2, 4 and 8-week treatment periods, and in morning trough FEV1 after 12 week treatment period(12 weeks)
- Mean pre-dose (and pre-rescue) Peak Expiratory Flow (PEF) as assessed via Asthma Monitor2+ (AM2+) device (in the morning and evening) of the last week of the 12-week treatment period(12 weeks)
- Mean rescue medication use (daytime and night-time) as assessed via AM2+ device (in the morning and evening) of the last week of the 12-week treatment period(12 weeks)
- Asthma control questionnaire (ACQ-6).(12 weeks)
- Asthma quality of life questionnaire (AQLQ(S)+12)(12 weeks)
- Time to withdrawal due to first asthma exacerbation(12 weeks)
- Daytime 12-h FEV1 profiles after 12-week treatment period (FEV1 Area Under Curve (AUC) 0-12h)(12 weeks)