NCT00658255已完成2 期
A Randomized, Multicenter, Open-label, Active-controlled, Single-dose, 5-period, Incomplete Block, Cross-over Study to Evaluate the Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort pMDI or Oxis Turbuhaler to Adults With Stable Asthma
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
- 175
- 主要终点
- Average FEV1 during 12 hours
研究概览
简要总结
The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.
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
- None
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
- •At least 18 years of age
- •Diagnosis of asthma and baseline lung function tests as determined by the protocol
- •Required and received treatment with inhaled corticosteroids within timeframe and doses specified in the protocol
排除标准
- •Severe asthma
- •Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers
研究组 & 干预措施
2
Active Comparator
干预措施: formoterol (Drug)
1
Experimental
干预措施: budesonide/formoterol (Drug)
结局指标
主要结局
Average FEV1 during 12 hours
时间窗: Once a week for 5 weeks during treatment period
次要结局
- Urine levels of formoterol in 2 different formulations(Once a week (12 hour urine collection) for 5 weeks during treatment period)
- Safety profiles of formoterol in 2 different formulations(Once a week for 5 weeks during treatment period)
研究者
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