A Randomized, Double Blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of 6-week Treatment With Oral Doses of 50 mg b.i.d., 200 mg b.i.d., and 400 mg b.i.d. BI 671800 ED in Steroid-naïve Patients With Persistent Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 389
- 试验地点
- 92
- 主要终点
- Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment
研究概览
简要总结
This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.
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
- 18 Years 至 65 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
BI 671800 (high dose)
Patients receive BI 671800 (high dose) capsules twice daily
干预措施: Fluticasone propionate placebo (Drug)
BI 671800 (low dose)
Patients receive BI 671800 (low dose) capsules twice daily
干预措施: BI 671800 (Drug)
BI 671800 (low dose)
Patients receive BI 671800 (low dose) capsules twice daily
干预措施: Fluticasone propionate placebo (Drug)
Fluticasone propionate
Patients inhale from Fluticasone propionate metered dose inhaler (MDI) twice daily
干预措施: Fluticasone propionate (Drug)
Fluticasone propionate
Patients inhale from Fluticasone propionate metered dose inhaler (MDI) twice daily
干预措施: BI 671800 Placebo (Drug)
Placebo
Patients receive placebo capsules twice daily
干预措施: Fluticasone propionate placebo (Drug)
Placebo
Patients receive placebo capsules twice daily
干预措施: BI 671800 Placebo (Drug)
BI 671800 (medium dose)
Patients receive BI 671800 (medium dose) capsules twice daily
干预措施: BI 671800 (Drug)
BI 671800 (medium dose)
Patients receive BI 671800 (medium dose) capsules twice daily
干预措施: Fluticasone propionate placebo (Drug)
BI 671800 (high dose)
Patients receive BI 671800 (high dose) capsules twice daily
干预措施: BI 671800 (Drug)
结局指标
主要结局
Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment
时间窗: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.
Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit. MMRM in the statistical test comments is mixed effects model with repeated measures.
次要结局
- Asthma Control Questionnaire (ACQ) Mean Score Change From Baseline After Six Weeks of Treatment(Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.)