NCT00628953已完成2 期
A Randomized, Double-Blind, Parallel Group Multicenter Efficacy and Safety Phase IIB Pilot Study of Esomeprazole 40mg Bid Versus Placebo Bid in Adult Asthmatics Treated for 4 Months
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,400
- 主要终点
- Effect on asthma symptoms as measured by changes in Peak Expiratory Flow morning & evening, Forced Expiratory Volume and asthma symptom scores
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of Nexium in the treatment of subjects with persistent asthma believed to have acid reflux as a contributory factor to control of their asthma.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of asthma
- •Forced Expiratory Volume and Peak Expiratory Flow as defined by the protocol
- •Daily use of inhaled GCS and/or leukotriene pathway modifier for greater than 3 months.
- •Severe heartburn 3 days/week during the run-in period.
排除标准
- •Subjects with a history of 3 sinus infections treated with antibiotics in the year prior to Visit
- •Any other significant disease or pathology judged to be clinically significant by the investigator
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo (Drug)
1
Experimental
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Effect on asthma symptoms as measured by changes in Peak Expiratory Flow morning & evening, Forced Expiratory Volume and asthma symptom scores
时间窗: 4 weekly
次要结局
- Safety as assessed by adverse event recording and clinical and laboratory measurements.(4 weekly)
研究者
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