NCT00402948终止2 期
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, To Evaluate And Compare The Safety, Tolerability And Efficacy Of Two Dosages Of Inhaled TPI ASM8 Administered For 14 Days In Patients With Mild to Moderate Asthma.
Syntara10 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2007年2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
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 10
- 主要终点
- Sputum eosinophils at Day 1 and Day 14 and safety on Day 14
研究概览
简要总结
This study will evaluate the efficacy, safety and tolerability of two dosages of a new drug TPI ASM8 administered by inhalation for 14 days to mild to moderate asthmatic patients, aged between 18-65, non-smokers . The study will also look at the nature and quantity of inflammatory white cells in the lung secretions and in the blood, and some additional inflammation markers.
详细描述
See above
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 y. old, non or ex-smokers for > 6 months
- •Mild to moderate asthmatic in general good health
- •On either low-dose inhaled corticosteroid or steroid naive
- •No other asthma medication
- •Regular sputum producer
- •EOS more than 3% at randomization,
- •FEV1 > 70%
排除标准
- •Respiratory infection within last 4 weeks
- •Any condition that may affect the conduct of the study as per the investigators
研究组 & 干预措施
TPI ASM8
Experimental
ASM8 0.25mg
干预措施: TPI ASM8 (Drug)
ASM8 as TPI ASM8
Experimental
TPI ASM8 0.5mg
干预措施: ASM8 (Drug)
结局指标
主要结局
Sputum eosinophils at Day 1 and Day 14 and safety on Day 14
时间窗: Prospective
次要结局
- FEV 1 on Day 1 and Day 14(Prospective)
- Rescue Medication (albuterol)for 21 days(Prospective)
- Gene expression ( mRNA, beta-chain and CCR3 on surface receptors of IL-3, IL-5 and GM-CSF(Prospective)
- Blood eosinophils at Day 0 and Day 15(Prospective)
研究者
研究点 (10)
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