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
- 445
- 试验地点
- 63
- 主要终点
- percent change in FEV1 from visit predose averaged over the 8-week double-blind period
研究概览
简要总结
The primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol 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
This was a Phase III, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group study of up to 9 weeks in duration. Seven days of QID single-blind placebo administration (via MDI) was followed by 56 days of QID double-blind active treatment. Following the run-in period, each subject was randomized to one of the following three treatments: levalbuterol HFA MDI 90 mcg (2 actuations of 45 mcg), racemic albuterol HFA MDI 180 mcg (2 actuations of 90 mcg), or placebo (2 actuations). Subjects were randomized in a 2:1:1 ratio of levalbuterol to racemic albuterol to placebo. In order to maintain blinding of the device, a placebo dose was administered with each treatment. 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, Investigator, Outcomes Assessor)
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
1
levalbuterol MDI 90 mcg QID
干预措施: levalbuterol tartrate MDI (Drug)
2
racemic albuterol MDI 180 mcg QID
干预措施: racemic albuterol MDI (Drug)
3
Placebo MDI QID
干预措施: Placebo (Drug)
结局指标
主要结局
percent change in FEV1 from visit predose averaged over the 8-week double-blind period
时间窗: Weeks 0, 4, 8
次要结局
- area under the FEV1 percent change curve from visit pre-dose and from study baseline curves averaged over the double-blind period(Weeks 0, 4, 8)
- peak percent change in FEV1 from study baseline(Weeks 0, 4, 8)
- peak change in FEV1 from visit predose(Weeks 0, 4, 8)
- peak percent of predicted FEV1(Weeks 0, 4, 8)
- area under the FEV1 curve (AUC)(Weeks 0, 4, 8)
- peak change and peak percent change in FEF25-75% from visit predose(Weeks 0, 4, 8)
- peak change and peak percent change in FVC from visit predose(Weeks 0, 4, 8)