NCT00651651已完成3 期
A 12 Week Randomized, Double-blind, Double-Dummy, Placebo-controlled Trial of Symbicort TM (160/4.5mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Children (at Least 6years of Age) and Adults With Asthma-SPRUCE 80/4.5
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
- 450
- 主要终点
- 12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation
研究概览
简要总结
The purpose of this study is to compare Symbicort with its monocomponents budesonide and formoterol in the treatment of asthma in children and adults
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 years of age
- •Diagnosis of asthma
- •Baseline lung function test results as determined by protocol and required and received treatment with inhaled corticosteroids and/or lung treatments specified in protocol within the 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 the protocol or requires treatment with beta-blockers
- •Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator
研究组 & 干预措施
1
Experimental
Symbicort
干预措施: budesonide/formoterol (Drug)
2
Active Comparator
budesonide
干预措施: budesonide (Drug)
3
Active Comparator
formoterol
干预措施: formoterol (Drug)
结局指标
主要结局
12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation
时间窗: FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period
次要结局
- Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments(Throughout the treatment period)
研究者
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