NCT00536913已完成3 期
A 4-week, Open-label, Randomized, Multi-centre, Parallel-group Study Evaluating the Safety and Efficacy of 4 Actuations Symbicort® (Budesonide/Formoterol) HFA pMDI 40/2.25 μg Twice Daily, With and Without Spacer, in Children (6-11 Years) With 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
- 107
- 试验地点
- 1
- 主要终点
- Urinary Free Cortisol (UFC)
研究概览
简要总结
The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of steroid potency, improvement of lung function and asthma symptoms in children with asthma (6-11 years).
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
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children 6-11 years, diagnosed asthma treated
- •6 months, PEF
- •50% of predicted normal value pre-bronchodilator
排除标准
- •current systemic glucocorticosteroids usage
- •current respiratory infection
- •any significant disease or disorder as judged by investigator
研究组 & 干预措施
With Spacer
Experimental
Budesonide/formoterol pMDI 40/2.25ug + spacer
干预措施: Budesonide/formoterol pMDI 40/2.25ug + spacer (Drug)
Without Spacer
Experimental
Budesonide/formoterol pMDI 40/2.25 ug
干预措施: Budesonide/formoterol pMDI 40/2.25 ug (Drug)
结局指标
主要结局
Urinary Free Cortisol (UFC)
时间窗: At baseline and 4 weeks
Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment
次要结局
- Forced Expiratory Volume in 1 Second (FEV1)(At baseline, at 2 weeks and 4 weeks)
- Morning Peak Expiratory Flow (mPEF)(Daily during run-in and daily during treatment period of 6 weeks)
- Evening Peak Expiratory Flow (ePEF)(Daily during run-in and daily during treatment period of 6 weeks)
- Asthma Symptoms at Night(Daily during run-in and daily during treatment period of 6 weeks)
- Asthma Symptoms at Day(Daily during run-in and daily during treatment period of 6 weeks)
- Percentage of Nights With Awakenings Due to Asthma(Daily during run-in and daily during treatment period of 6 weeks)
- Use of Rescue Medication at Night(Daily during run-in and daily during treatment period of 6 weeks)
- Use of Rescue Medication at Day(Daily during run-in and daily during treatment period of 6 weeks)
研究者
研究点 (1)
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