NCT00725582已完成1 期
The Effects of IMA-026 on Allergen-Induced Airway Responses and Airway Inflammation in Subjects With Mild Atopic Asthma
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 24 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Comparison of the maximum change in FEV1 from baseline for the LAR between IMA-026 and placebo
研究概览
简要总结
The purpose of this study is to evaluate the effect of IMA-026, an antibody to IL-13, on airway hyperresponsiveness and airway inflammation in mild asthmatics. IMA-026 will be given as 2 injections under the skin 1 week apart at 2 mg/kg each dose. The study will include a screening period and a treatment period which includes doses on day 1 and day 8.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy men and women 18 to 60 yrs with mild allergic asthma
- •only asthma med is short-acting bronchodilator used not more than twice weekly
- •FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction
排除标准
- •Upper respiratory infection or asthma exacerbation with 4 weeks of screening
- •Serious infection requiring parenteral antibiotics or hospitalization with 4 weeks of test article administration
- •Positive radiographic findings indicative of respiratory disease other than asthma
研究组 & 干预措施
A
Experimental
干预措施: IMA-026 (Drug)
B
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Comparison of the maximum change in FEV1 from baseline for the LAR between IMA-026 and placebo
时间窗: 11 weeks
次要结局
- Treatment comparison of the hour 3 and hour 7 FEV1 AUC for the LAR; various comparisons of the methacholine PC20(11 weeks)
研究者
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