NCT01740986已完成2 期
Double Blinded, Randomized, Placebo Controlled, Multi-center, Phase II Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients
SamA Pharmaceutical Co., Ltd14 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 14
- 主要终点
- Mean change from baseline of PEF(Peak Expiratory Flow)at week 6
研究概览
简要总结
Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis or presence of asthma within 3 months of the prestudy visit
- •Increase in PEF ≥ 20% or ≥ 60L/min from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit
- •Increase in FEV1 ≥ 12% and ≥ 200mL from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit
- •FEV1 or PEF between 60% and 85% of the predicted value at screening or within the 3 months of the prestudy visit
- •Having signed an informed consent
排除标准
- •Patient who has severe asthma
- •Patient who has any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study other protocol-defined inclusion/exclusion criteria may apply
- •Patient with an AST or ALT > 2x ULN (upper limit of normal) in the screening visit
- •Patient with more than 10 pack year of cigarettes history
研究组 & 干预措施
SA09012 Low dose
Experimental
干预措施: SA09012 Low dose (Drug)
SA09012 High dose
Experimental
干预措施: SA09012 High dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change from baseline of PEF(Peak Expiratory Flow)at week 6
时间窗: 6 week treatment period
次要结局
- Mean change from baseline in FEV1 at week 6(6 week treatment period)
- Mean change from baseline in ACT(Asthma Control Test) at week 6(6 week treatment period)
- Safety assessment(Comparison of the adverse event profiles throughout the course of the study)(6 week treatment period)
研究者
研究点 (14)
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