A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study Assessing Efficacy and Safety of a 12 Week Treatment With BI 54903 Administered at 90.9 Mcg b.i.d. and 181.8 Mcg q.d. (p.m.Dosing) Via Respimat® Inhaler in Patients With Asthma Inadequately Controlled on Short Acting Beta-2 Agonist (SABA) Therapy Alone
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 doses of very low dose twice daily (b.i.d) and low dose once daily (evening dosing) and placebo over an 12-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on short acting beta-2 agonist (SABA) therapy alone as demonstrated by a decrease in forced expiratory volume in 1 second (FEV1) (not less than 10 %, and equal to or less than 25%) and an Asthma Control Questionnaire (ACQ-6) 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
Placebo
Patients receive 2 puffs b.i.d. via Respimat inhaler
干预措施: Placebo matching Respimat (Drug)
BI 54903 LD b.i.d.
Patients receive 2 puffs b.i.d. via Respimat inhaler
干预措施: BI 54903 (Drug)
BI 54903 MD q.d.
Patients receive 2 puffs q.d. via Respimat inhaler (p.m.) combined with 2 puffs placebo (a.m.)
干预措施: BI 54903 MD (Drug)
BI 54903 MD q.d.
Patients receive 2 puffs q.d. via Respimat inhaler (p.m.) combined with 2 puffs placebo (a.m.)
干预措施: Placebo matching Respimat (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
- Daytime 12-h FEV1 profiles after 12-week treatment period (FEV1 AUC0-12h)(12 weeks)
- Asthma control questionnaire (ACQ-6)(12 weeks)
- Asthma quality of life questionnaire (AQLQ(S)+12)(12 weeks)
- 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) 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) PEF as assessed via 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)
- Time to withdrawal due to first asthma exacerbation(12weeks)
- Mean change from randomisation baseline in morning and evening trough (pre-dose and pre-rescue bronchodilator) FEF25-75 after 2, 4, 8 and 12 week treatment periods(2, 4, 8 and 12 weeks)