Short- and Long Term Growth in Children With Asthma Treated With Budesonide or Montelukast
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Lower leg growth rate
研究概览
简要总结
The purpose of this study is to assess if treatment with budesonide 200 microgram per day affects short- or long term growth in children with asthma
详细描述
When children with asthma are treated with inhaled corticosteroids there is a risk of systemic adverse events such as growth suppression. It has been reported that treatment with budesonide 200 microgram per day does not affect short term growth in children with asthma. The aim of the present study is to assess if an unaffected short term growth means that also long term growth will be unaffected.
Short and long term growth in asthmatic children treated with budesonide will be compared with the growth in asthmatic children treated with montelukast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •age 6-11,
- •prepubertal,
- •normal weight and height,
- •informed consent
排除标准
- •treatment with systemic/inhaled/intranasal corticosteroids within the last week,
- •major surgery within 4 weeks,
- •usage of drugs that significantly inhibit CYP3A4
研究组 & 干预措施
1
Budesonide
干预措施: Budesonide (Drug)
2
Montelukast
干预措施: Montelukast (Drug)
结局指标
主要结局
Lower leg growth rate
时间窗: one year
Height
时间窗: one year
次要结局
未报告次要终点