NCT01232322已完成不适用
Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation for Long-term Use in Pediatrics
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 633
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy for long term treatment of the drug in children aged 6 months and < 5 years on bronchial asthma in daily clinical usage.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated with Pulmicort Respules for the first time due to bronchial asthma
- •Children of >= 6 months and < 5 years old age at the start of study treatment
排除标准
- 未提供
结局指标
主要结局
Incidence of Adverse Events
时间窗: Range of 3 years
Effects on growth rate
时间窗: Range of 3 years
Variation of the height/weight from the baseline.
Effects on the adrenal cortical function.
时间窗: Range of 3 years
Symptoms of adrenal cortical function suppression before and after the treatment with Pulmicort.
Effects on development of infections.
时间窗: Range of 3 years
Existence and type of infections.
次要结局
- Clinical course under Pulmicort long-term use
研究者
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