NCT01820481已完成2 期
Double Blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in Asthma Patients
Whanin Pharmaceutical Company1 个研究点 分布在 1 个国家目标入组 209 人开始时间: 2012年9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
- 209
- 试验地点
- 1
- 主要终点
- Compare the change of FEV1% to the baseline after the medication
研究概览
简要总结
This clinical trial is designed to evaluate the efficacy, dose-response and safety of WIN-901X in Asthma patients.
详细描述
Double blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in 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
- Double (Participant, 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
- •Greater than or equal to 20 and less than 80 years of age
- •Have physician diagnosed asthma with irreversible airway obstruction at least 6 months prior to the screening
- •FEV1 between 60% and 85% before inhaling fast-acting bronchodilator at screening
- •No history of smoking at least one year prior to the screening
- •Having voluntarily signed an informed consent
排除标准
- •Have visited emergency room due to the worsening asthma symptoms, within 4 weeks before the screening
- •Have been hospitalized due to an acute worsening of asthma within 3 months before the screening
- •Have a history of laryngitis, pyrexia, sinusitis, otitis media, respiratory tract infection, and infectious rhinitis within 4 weeks prior to the screening
- •Have malignant tumor
研究组 & 干预措施
Treatment 3
Experimental
干预措施: WIN-901X dose level 3 (Drug)
Treatment 1
Experimental
干预措施: WIN-901X dose level 1 (Drug)
Treatment 2
Experimental
干预措施: WIN-901X dose level 2 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Compare the change of FEV1% to the baseline after the medication
时间窗: Baseline, week 12
FEV1: Forced Expiratory Volume In One Second
次要结局
- Ratio of the date, where no rescue drug was used, during the trial(Baseline, week 12)
- Ratio of symptom free days during the trial(Baseline, week 12)
- Compare the change of ACQ to the baseline after the medication(Baseline, week 12)
研究者
研究点 (1)
Loading locations...
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