A Randomised, Double-blind, Double-dummy, Active-controlled, Parallel-group Study to Assess and Compare Efficacy and Safety of an 8-week Treatment With BI 54903 at Doses of 90.9, 181.8 and 363.6 µg b.i.d. Administered Via Respimat® Inhaler and Fluticasone Propionate HFA MDI 440 µg b.i.d. in Patients With Asthma Inadequately Controlled on Medium Dose ICS Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 37
- 主要终点
- Mean Change From Randomisation Baseline to the End of the 8-week Treatment Period in Trough (Morning 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 three different dosages (b.i.d)., fluticasone propionate hydrofluoroalkane (HFA) metered dose inhaler (MDI) at a dose of 440 mcg b.i.d and low dose fluticasone propionate 88 mcg b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled medium dose ICS therapy as demonstrated by a decrease in forced expiratory volume in one second (FEV1) range 10 to 25 % and an asthma control questionnaire-6 (ACQ-6) equal or greater 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 low dose
patient to receive Respimat inhaler containing low dose BI 54903 plus placebo matching hydrofluoroalkane (HFA) metered dose inhaler (MDI)
干预措施: BI 54903 (Drug)
BI 54903 low dose
patient to receive Respimat inhaler containing low dose BI 54903 plus placebo matching hydrofluoroalkane (HFA) metered dose inhaler (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: 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)
BI 54903 high dose
Respimat inhaler containing high dose BI 54903 plus placebo matching HFA MDI
干预措施: BI 54903 (Drug)
Fluticasone propionate 440 mcg BID
Fluticasone HFA MDI containing 440 mcg ICS plus placebo matching Respimat inhaler
干预措施: Fluticasone propionate (Drug)
Fluticasone propionate 88 mcg BID
Fluticasone HFA MDI containing 88 mcg ICS plus placebo matching Respimat inhaler
干预措施: Fluticasone propionate (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 (Morning Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in One Second (FEV1)
时间窗: At baseline and week 8
Mean change from randomisation baseline to the end of the 8-week treatment period in trough (morning pre-dose and pre-rescue bronchodilator) Forced expiratory volume in one second (FEV1).
次要结局
- Mean Changes From Randomization Baseline in Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Forced Vital Capacity (FVC) After 2, 4 and 8-week Treatment Periods(At baseline and week 2, 4, 8.)
- Mean Changes From Randomization Baseline in Trough (Morning Pre-dose and Pre-rescue Bronchodilator) FEV1 After 2 and 4-week Treatment Periods(At baseline and week 2 and 4.)
- Mean Pre-dose (and Pre-rescue) Peak Expiratory Flow (PEF) as Assessed Via Asthma Monitor2+ (AM2+) in the Morning and Evening of the Last Week of the 8-week Treatment Period(At week 8.)
- Mean Rescue Medication Use (Daytime and Night-time) as Assessed Via 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 ACQ-6 Scores at Subsequent Study Visits(At baseline and week 2, 4, 8.)
- Mean Change From Randomisation Baseline in Asthma Quality of Life Questionnaire (AQLQ(S)+12) Scores at Subsequent Study Visits(At baseline and week 2, 4, 8.)
- Time to Withdrawal Due to First Asthma Exacerbation(At week 8.)
- Mean Change From Randomization Baseline in Through (Morning Pre-dose and Pre-rescue Bronchodilator) FEF 25-75 After 2, 4 and 8-week Treatment Periods(At baseline and week 2, 4 and 8.)