ACTRN12623000670673招募中3 期
An open-label randomised controlled trial of as-needed budesonide-formoterol vs. salbutamol reliever therapy in preschool children with mild asthma/recurrent wheeze.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 24 Months 至 59 Months（—）
- 性别
- All
入选标准
- •1. Aged 24 to 59 months; AND
- •2. >=3 wheezing episodes in the last 12 months (at least one doctor or nurse prescriber diagnosed); AND
- •3. Prescription of SABA in the last 12 months.
排除标准
- •1. Previous life-threatening asthma/wheeze (intensive care unit admission or intravenous treatment); OR
- •2. Self-reported use of more than six SABA MDIs in the last 12 months (i.e. poorly controlled); OR
- •3. Use of asthma medications other than SABA or ICSs (LABA, leukotriene receptor antagonist, theophylline, anticholinergic agent or cromone) in last 3 months; OR
- •4. Significant other comorbidity including, but not limited to, cystic fibrosis and bronchiectasis or arrhythmia; OR
- •5. Unable or unwilling to switch from current treatment regimen; OR
- •6. Ex-preterm infant (born <37 weeks' gestation); OR
- •7. Children living outside urban areas (i.e. significant distance from ambulance or hospital).
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