NCT00646009已完成3 期
A Randomized, Multicenter, Placebo and Active-controlled, Single-dose, 4-period, Crossover Study to Evaluate the Bronchodilating Effect of SYMBICORT pMDI Versus Advair Diskus and Ventolin HFA.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 48
- 主要终点
- FEV1 3 minutes post dose
研究概览
简要总结
The purpose of this study is to compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with 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
- Double
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 test results as determined by the protocol
- •Required and received inhaled corticosteroids within timeframe and doses specified in the protocol
排除标准
- •Severe asthma or asthma that is markedly effected by seasonal factors
- •Has required and received non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
研究组 & 干预措施
1
Experimental
budesonide/formoterol
干预措施: budesonide/formoterol (Drug)
2
Active Comparator
fluticasone/salmeterol
干预措施: fluticasone/salmeterol (Drug)
3
Active Comparator
albuterol
干预措施: albuterol (Drug)
结局指标
主要结局
FEV1 3 minutes post dose
时间窗: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
次要结局
- 12 hour serial FEV1(4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart))
- Patients perception of effect(Patients perception of effect)
研究者
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