Long Term Safety Study of Levalbuterol and Racemic Albuterol 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
- 746
- 试验地点
- 95
- 主要终点
- incidence of post-randomization adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.
详细描述
This was a randomized, open-label, active controlled, multicenter, parallel-group safety study in subjects 12 years of age and older with asthma. Subjects of appropriate age who completed the Phase III levalbuterol HFA MDI trials (Studies 051-353 or 051-355) were eligible to participate. Studies 051-353 and 051-355, both entitled "An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma" were multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group studies of up to nine weeks in duration (a one-week single-blind placebo run in period followed by an eight-week double-blind treatment period). Subjects who completed Studies 051 353 and 051 355 but who were not immediately eligible to rollover into the current study could also participate but only after a 30-day washout. New subjects and subjects who participated in the Phase III trials who were not immediately eligible (ie, had a >30-day washout) were considered to be de novo subjects.Study participation included 10 study visits over a 12 month period.
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
- None
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 90 mcg MDI QID
干预措施: levalbuterol tartrate HFA MDI (Drug)
2
racemic albuterol HFA MDI 180 mcg QID
干预措施: racemic albuterol (Drug)
结局指标
主要结局
incidence of post-randomization adverse events
时间窗: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
次要结局
- rate of discontinuations due to adverse events(Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53)
- time-to-selected adverse events (AEs with an incidence ≥5%)(Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53)
- asthma attacks, asthma adverse events, and expanded-definition asthma events(Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53)
- clinical laboratory values(Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53)
- vital signs (blood pressure, heart rate, respiration rate, and body temperature)(Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53)
- ECG parameters(Weeks -1, 0, 1, 10, 11, 26, 27, 43, 44, 52, 53)
- physical examinations(Weeks -1, 0, 26, 27, 52, 53)
- rescue medication, and daytime asthma control days(Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53)
- FEV1, FVC, FEF25-75%, peak expiratory flow(Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53)
- Asthma Quality of Life Questionnaire (AQLQ)(Weeks 0, 26, 27, 52, 53)
- subject and physician global evaluations(Weeks 26, 27, 52, 53)
- (S) and (R) albuterol plasma concentrations(Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53)
- subject assessment of study inhaler device performance(Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53)