NCT00272753已完成4 期
A Randomized Double Blind Comparison Between Single Doses of Symbicort Turbuhaler (Budesonide/Formoterol Combination), Formoterol, Salbutamol and Placebo in Repeated AMP-challenges in Patients With Mild - to Moderate Asthma. Investigating the Supplementary Value of the Budesonide Component Within Symbicort When Tested in a Model of Slow Onset Acute Asthma
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The decrease in lung function (FEV1) after the third AMP provocation test.
研究概览
简要总结
The aim is to study whether the budesonide component within the budesonide/ formoterol combination inhaler has additive value in a model of "slow onset acute asthma" , namely three AMP provocation tests performed on one day
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •asthma diagnosis according to ATS criteria,
- •lung function (FEV1) above 60% of predicted,
- •AMP-PC20 below 160 mg/ml with a documented fall in FEV1 of 30% in this provocation test
排除标准
- •having smoked > 10 Pack-years,
- •hypersensitivity to one of the study drugs,
- •significant co-morbidity, pregnancy or lactating
结局指标
主要结局
The decrease in lung function (FEV1) after the third AMP provocation test.
次要结局
- Decrease in lung function (FEV1) after the second AMP provocation test,
- lung function and Borg Score over the test day,
- increase in FEV1 at three minutes after study drug inhalation,
- time course of recovery from the AMP-induced decrease in lung function
研究者
研究点 (2)
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