NCT00268723已完成3 期
An Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Versus Placebo in Prevention of EIB in Subjects 18 Years of Age and Older With EIB
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- maximum percent FEV1 decrease from visit postdose/prechallenge
研究概览
简要总结
To determine if administration of levalbuterol tartrate HFA MDI in subjects with EIB will be effective in the prevention of EIB and be safe and well-tolerated.
详细描述
This was a randomized, double-blind, placebo-controlled, multicenter, two-way crossover study of levalbuterol tartrate HFA MDI in subjects 18 years of age and older with EIB. 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
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（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
Experimental
levalbuterol HFA MDI 90 mcg QID
干预措施: Levalbuterol tartrate HFA MDI (Drug)
2
Placebo Comparator
Placebo MDI QID
干预措施: Placebo (Drug)
结局指标
主要结局
maximum percent FEV1 decrease from visit postdose/prechallenge
时间窗: Days 1, 4, 7
次要结局
- FEV1 area under the curve (AUC0-60 mins) (% decrease from visit postdose/prechallenge)(Days 1, 4, 7)
- time to FEV1 recovery(Days 1, 4, 7)
- minimum percent change in FEV1 from visit postdose/prechallenge(Days 1, 4, 7)
- minimum percent change in FEV1 from visit predose(Days 1, 4, 7)
- protected/unprotected subject counts (unprotected: >20% decrease; moderately protected: 10% to 20% decrease; and protected: <10% decrease from postdose/prechallenge FEV1)(Days 1, 4, 7)
- percent change in FEV1 from predose to postdose/prechallenge(Days 1, 4, 7)
研究者
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