NCT00163371已完成3 期
Effect of Ciclesonide (320 mcg/Day) vs Fluticasone Propionate (375 mcg/Day) vs. Placebo on Short-term Linear Growth Rate and HPA-axis Function in Prepubertal Children With Mild Asthma
适应症
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
- 28
- 试验地点
- 2
- 主要终点
- growth velocity of the right lower leg as measured by knemometry.
研究概览
简要总结
The aim of the study is to compare the effects of ciclesonide inhaled at one dose level twice daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on short-term lower leg growth in prepubertal children with mild persistent asthma. The study duration consists of a baseline period (2 weeks), a treatment period (2 weeks for each treatment), and a wash-out period (2 weeks). The study will provide further data on safety and tolerability of ciclesonide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent by the patient's parent(s) or legal guardian(s) and by the patient, if capable
- •Prepubertal stage
- •Good health with the exception of asthma
- •History of asthma for at least 6 months
- •Currently using rescue medication only
排除标准
- •Childbearing potential (beyond menarche)
- •Concurrent diseases or conditions which may subsequently affect growth
- •COPD or relevant lung diseases causing alternating impairment in lung function
- •Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- •History of life-threatening asthma
- •Current smoking
结局指标
主要结局
growth velocity of the right lower leg as measured by knemometry.
次要结局
- weight and height
- HPA-axis function
- vital signs, including blood pressure, pulse rate
- lung function from spirometry
- asthma symptom score, use of rescue medication from diary
- adverse events
- physical examination
- laboratory investigation.
研究者
研究点 (2)
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