NCT01805687已完成4 期
A Single-Center, Open-Label, Single-Dose Evaluation of the Duration and Extent of Bronchodilation Following Administration of Zileuton CR 1200 mg in Subjects With Stable, Chronic Asthma
Cornerstone Therapeutics Inc.1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2013年3月最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change From Baseline in FEV1
研究概览
简要总结
Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma for at least 5 years
- •FEV1 of 50-85% predicted
- •Reversible airway obstruction
排除标准
- •Pregnant/nursing females
- •Liver function tests greater than upper limit of normal
研究组 & 干预措施
Zileuton extended release
Other
Oral, 1200 mg (2 x 600 mg tablets)
干预措施: Zileuton extended release (Drug)
结局指标
主要结局
Change From Baseline in FEV1
时间窗: 12 Hours
次要结局
- Area Under the Curve (AUC)(72 Hours)
- Number of Subjects With Adverse Events(72 Hours)
研究者
研究点 (1)
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