NCT00141791已完成2 期
A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 25mg Twice Weekly in Subjects With Moderate to Severe Persistent Asthma
Wyeth is now a wholly owned subsidiary of Pfizer13 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2005年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 13
- 主要终点
- Change in FEV1% predicted from baseline to week 12 (before bronchodilator administration).
研究概览
简要总结
The primary objective of the study is to assess the efficacy and safety of etanercept 25 mg given twice weekly in subjects with moderate to severe persistent asthma.
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe persistent asthma for at least 1 year
- •Demonstrated reversibility of at least 9% and (FEV1) 50% to 80% predicted
- •Subjects must be on a high-dose inhaled corticosteroid (ICS)
排除标准
- •Previous treatment with etanercept
- •Current use of cigarettes
- •Significant concurrent medical conditions at the time of screening
结局指标
主要结局
Change in FEV1% predicted from baseline to week 12 (before bronchodilator administration).
次要结局
- Peak expiratory flow rate, Asthma control questionnaire, Asthma exacerbations.
研究者
研究点 (13)
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