An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 386
- 试验地点
- 54
- 主要终点
- FEV1 (peak percent change from pre-dose averaged over the double-blind period).
研究概览
简要总结
The primary objective of this study is to investigate the efficacy of levalbuterol 90 ug (2 actuations, 45 ug each) versus placebo (2 actuations) in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).
详细描述
A double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group trial of levalbuterol in subjects 12 years of age and older with asthma. Study participation will include one 1-week single-blind placebo run-in and an 8-week, randomized,double-blind, active-treatment period with four treatment groups. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
I
Levalbuterol 90 ųg QID (manufacturing site A or B)
干预措施: levalbuterol (Drug)
II
Racemic Albuterol 180 ųg QID
干预措施: levalbuterol (Drug)
III
Placebo QID
干预措施: levalbuterol (Drug)
结局指标
主要结局
FEV1 (peak percent change from pre-dose averaged over the double-blind period).
时间窗: 8 weeks
次要结局
- --FEV1 [area under the % change from pre-dose FEV1 curve] and FEV1 [area under the % change from study baseline FEV1 curve](9 weeks)