NCT01424124已完成2 期
Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of YHD001 Following 8 Weeks Oral Administration of YHD001 in Patients With Partially Controlled Asthma
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2011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
- 56
- 试验地点
- 1
- 主要终点
- Change from baseline of FEV1 at week 4
研究概览
简要总结
The main objective is to evaluate the safety/tolerability and efficacy of YHD001 compared to singulair or placebo in patients (n=96) with partially controlled asthma.
The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), singulair 10mg(q.d.) or Placebo for 8 weeks.
详细描述
Singulair: Montelukast sodium (leukotriene modulator)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed written informed consent
- •Acceptable medical history, physical exam,laboratory tests and EKG, during screening
- •Nonsmoking (for longer than 1 year) patients with asthma
- •Reversible airways obstruction (an increase in FEV1 absolute value of 12% or greater) 20 to 30 minutes after inhalation of b-agonist
- •FEV1 between 50% and 85% of the predicted value (withholding short-acting, inhaled b2-adrenergic agonist for 6 hours)
排除标准
- •History of any clinically significant disease
- •History of drug/chemical/alcohol abuse
- •Active upper respiratory tract infection within 3 weeks, emergency room treatment for asthma within 1 month, or hospitalization for asthma within 3 months of the prestudy visit
研究组 & 干预措施
YHD001 dose level 1
Experimental
干预措施: YHD001 dose level 1 (Drug)
YHD001 dose level 2
Experimental
干预措施: YHD001 dose level 2 (Drug)
Singulair
Active Comparator
干预措施: Singulair (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline of FEV1 at week 4
时间窗: Baseline, week 4
FEV1: Forced Expiratory Volume In One Second
次要结局
- Change from baseline of PEFR at week 8(Baseline, week 8)
- Change from baseline of ACT Score at week 8(Baseline, week 8)
- Change from baseline of using rescue medication(b-Agonist) at week 8(Baseline, week 8)
- safety assessment(week 9)
- Change from baseline of FEV1 at week 8(Baseline, week 8)
研究者
研究点 (1)
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