NCT00642122已完成3 期
A Randomized, Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of Pulmicort Respules at 0.5mg QD, 1.0mg QD, 1.0mg Bid, 2.0mg Bid and Pulmicort Turbuhaler at 4.00mcg Bid on Adolescents (12 Yrs of Age and Older) With Adults With Moderate to Severe Asthma.
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
- 900
- 主要终点
- Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg.
研究概览
简要总结
A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.
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
- Single
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 12 or over who have asthma
- •Ability to properly use an electronic diary
- •Able and willing to nebulize for up to 20 minutes every morning and evening
排除标准
- •Hospitalised at least one once or required emergency treatment due to asthma in the previous 6 months
- •Planned hospitalisation during the study
- •pregnant women or women planning to become pregnant
研究组 & 干预措施
1
Experimental
Pulmicort RESPULES
干预措施: Budesonide (Drug)
2
Experimental
Pulmicort TURBUHALER
干预措施: Budesonide (Drug)
结局指标
主要结局
Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg.
时间窗: Day -14, 1, and every 28 days thereafter
次要结局
- Percentage of symptom free days(Day -14, 1, and every 28 days thereafter)
- Percentage of symptom free nights(Day -14, 1, and every 28 days thereafter)
- Percentage of symptom free 24-hours(Day -14, 1, and every 28 days thereafter)
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