Childhood Asthma and Return to School: the September Epidemic Exacerbation in Israel.A Controlled Trial of the Effectiveness of Preventive Treatment With Symbicort or Budicort Turbuhaler
试验速览
- 阶段
- 不适用
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- reduction of asthma exacerbation during the study period
研究概览
简要总结
During the second week of September( week 38 of the year)there are recorded data of exacerbation of asthma all over the world, including Israel. A short preventive treatment of 6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and hospitalization.
详细描述
During the second week of September( week 38 of the year)there are recorded data of exacerbation of asthma all over the world, including Israel. A short preventive treatment of 6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and hospitalization.
We will study the effectiveness of Budicort or Symbicort turbuhaler as a preventive treatment in children aged 6-18 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age : 6-18 years suffering from asthma asthma exacerbation during 1/9/2009-15/10/2009
排除标准
- •any chronic condition that can involve respiratory tract (other than asthma) treated as prevention with ICS or montelukast from July 2010 Treated with oral steroids during the August 2010 asthma exacerbation one week prior study inclusion
研究组 & 干预措施
Budicort
75 children will receive treatment with Budicort 200 mcg
干预措施: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler (Drug)
Symbicort
75 children will receive treatment with Symbicort 160 mcg
干预措施: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler (Drug)
counselling
75 children who will not treated as their request but will be folowedup
干预措施: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler (Drug)
结局指标
主要结局
reduction of asthma exacerbation during the study period
时间窗: An average time of 8 weeks
less asthma exacerbation
次要结局
- less primary care physician visits(An average time of 8 weeks)