KCT0000571已完成未知
Double blinded, Randomized, Placebo Controlled, Multicenter, Phase II Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients
Sama Pharm0 个研究点目标入组 234 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 234
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 79(Year)（—）
- 性别
- All
入选标准
- •1. Diagnosis or presence of asthma within 3 months of the prestudy visit
- •1) Increase in PEF = 20% or = 60L/min from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit
- •2) Increase in FEV1 = 12% and = 200mL from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit
- •2. FEV1 or PEF between 60% and 85% of the predicted value at screening or within the 3 months of the prestudy visit
- •3. Having signed an informed consent
排除标准
- •1. Emergency room treatment for asthma within 4 weeks of the prestudy visit
- •2. Hospitalization for asthma within 8 weeks of the prestudy visit
- •3. patients with severe asthma
- •4. Patients with 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
- •5. history of drug or chronic alcohol abuse
- •6. Participation in another clinical trial in the past 4 weeks
研究者
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