Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma - Randomized, Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Markers of bone metabolism (from serum and urine)
研究概览
简要总结
The purpose of the trial is to check if inhaled glucocorticosteroids (iGCS) have influence on bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with asthma.
详细描述
Asthma is the most prevalent chronic disease of respiratory tract, the largest frequency is noticed in children. iGCS are the basic group of drugs in asthma, because of inflammatory character of disease. All iGCS are absorbed to the systemic circulation (small amounts) despite of local exposition in lungs and possess systemic effects. The purpose of trial is to check if iGCS have influence on bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allergic only to house dust mites
- •Never treated chronically (longer than at least 3 months) with anti-asthmatic drugs
- •Newly-diagnosed or non-treated asthma
- •Must be able to inhale drugs
排除标准
- •Other allergic diseases requiring treatment with glucocorticosteroids
- •Other chronic diseases
- •Asthma exacerbation
- •Pregnancy
研究组 & 干预措施
1
budesonide
干预措施: budesonide (Drug)
2
D3 vitamin
干预措施: D3 vitamin (Drug)
3
montelukast sodium
干预措施: montelukast sodium (Drug)
4
salbutamol
干预措施: salbutamol (Drug)
结局指标
主要结局
Markers of bone metabolism (from serum and urine)
时间窗: Baseline and 6 months
次要结局
- Symptoms score (based on PAQLQ), spirometry(baseline and 6 months)