An Efficacy, Safety, and Tolerability Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 44
- 主要终点
- was peak percent change in FEV1 from visit predose averaged over the double-blind period
研究概览
简要总结
Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma
详细描述
This was a Phase III, double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group study of up to 6 weeks in duration. Seven days of QID single-blind, placebo administration (via HFA MDI) was followed by 28 days of QID, double-blind treatment. A follow-up visit was required only for subjects who had, in the opinion of the investigator, a clinically significant finding at Visit 6 /ET that would put the subject at risk. A final follow up phone evaluation was conducted 7 days after the completion of Visit 6/ET. 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
- 4 Years 至 11 Years（Child）
- 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 190 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
was peak percent change in FEV1 from visit predose averaged over the double-blind period
时间窗: Week 0, 2, 4
次要结局
- peak percent change in FEV1 from study baseline over the double blind period(Week 0, 2, 4)
- peak percent of predicted FEV1 at each visit and over the double-blind period(Week 0, 2, 4)
- area under the FEV1 percent change from predose curve at each visit(Week 0, 2, 4)
- percent of predicted FEV1 AUC at each visit(Week 0, 2, 4)
- percent change in predose FEV1 from study baseline at each visit(Week 0, 2, 4)
- number and percent of responders(Week 0, 2, 4)
- time to onset of response and duration of response(Week 0, 2, 4)
- peak change in FEV1 from visit predose to each visit(Week 0, 2, 4)
- time to peak change(Week 0, 2, 4)
- under the FEV1 percent change from visit predose curve averaged over the double-blind period(Week 0, 2, 4)
- peak change and peak percent change in FEV1 from visit predose to each visit(Week 0, 2, 4)
- area under the FEV1 percent change from study baseline curve at each visit and averaged over the double-blind period(Week 0, 2, 4)