A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess and Compare Efficacy and Safety of an 8-week Treatment With BI 54903 at Doses of 45.5, 90.9 and 181.8 mcg b.i.d. Administered Via Respimat® Inhaler and Fluticasone Propionate HFA 220 mcg b.i.d. in Patients With Asthma Inadequately Controlled on Low Dose ICS Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 41
- 主要终点
- Mean Change From Randomisation Baseline to the End of the 8-week Treatment Period in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in One Second (FEV1)
研究概览
简要总结
The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses twice daily (b.i.d.), fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA MDI) at a dose of 220 mcg b.i.d. and placebo b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on low dose Inhaled corticosteroid (ICS) as demonstrated by a decrease in forced expiratory volume in one second (FEV1 (range 10-25%) and an asthma control questionnaire (ACQ-6) greater or equal 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 - high dose
Respimat inhaler containing high dose BI 54903 plus placebo matching HFA MDI
干预措施: BI 54903 (Drug)
BI 54903 - low dose
Respimat inhaler containing low dose BI 54903 plus placebo matching hydrofluoralkane (HFA) metered dose inhaler (MDI)
干预措施: Placebo (Drug)
BI 54903 - low dose
Respimat inhaler containing low dose BI 54903 plus placebo matching hydrofluoralkane (HFA) metered dose inhaler (MDI)
干预措施: BI 54903 (Drug)
BI 54903 - medium dose
Respimat inhaler containing medium dose BI 54903 plus placebo matching HFA MDI
干预措施: Placebo (Drug)
BI 54903 - medium dose
Respimat inhaler containing medium dose BI 54903 plus placebo matching HFA MDI
干预措施: BI 54903 (Drug)
BI 54903 - high dose
Respimat inhaler containing high dose BI 54903 plus placebo matching HFA MDI
干预措施: Placebo (Drug)
Fluticasone propionate
Fluticasone HFA MDI containing ICS plus placebo matching Respimat inhaler
干预措施: Fluticasone propionate (Drug)
Placebo
Placebo matching Respimat inhaler plus placebo matching HFA MDI
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Randomisation Baseline to the End of the 8-week Treatment Period in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in One Second (FEV1)
时间窗: At baseline and at week 8.
Mean change from randomisation baseline to the end of the 8-week treatment period in trough (pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1).
次要结局
- Mean Changes From Randomisation Baseline in Trough (Morning Pre-dose and Pre-rescue Bronchodilator) FEF25-75 After 2, 4 and 8-week Treatment Periods(At baseline and at week 2, 4 and 8.)
- Mean Changes From Randomisation Baseline in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Vital Capacity (FVC) After 2, 4 and 8-week Treatment Periods(At baseline and at week 2, 4 and 8.)
- Mean Changes From Randomisation Baseline in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in One Second (FEV1) After 2 and 4-week Treatment Periods(At baseline and at week 2 and 4.)
- Mean Pre-dose (and Pre-rescue) Peak Expiratory Flow (PEF) as Assessed Via Asthma Monitor (AM2+) in the Morning and Evening, of the Last Week of the 8-week Treatment Period(8 weeks)
- Mean Rescue Medication Use (Daytime and Night-time) as Assessed Via Asthma Monitor (AM2+) in the Morning and Evening, of the Last Week of the 8-week Treatment Period(At week 8.)
- Mean Change From Randomisation Baseline in Asthma Control Questionnaire (ACQ-6) Scores at Subsequent Study Visits(At baseline and at week 2, 4 and 8.)
- Mean Change From Randomisation Baseline in Asthma Quality of Life Questionnaire (AQLQ(S)+12) Scores at Subsequent Study Visits(At baseline and at week 2, 4 and 8.)
- Time to Withdrawal Due to First Asthma Exacerbation(At week 8.)