NCT01203904已完成不适用
Pulmicort Turbuhaler 100/200 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
- 301
- 试验地点
- 1
- 主要终点
- Adverse event incidence. We will investigate, intensively, development of Adverse Drug Reactions, especially infections. Detection of Adverse Drug Reactions unexpected from the Precautions for use.
研究概览
简要总结
The purpose of this study is to confirm the safety profile for long term treatment in children aged 5 years and <15 years on bronchial asthma in daily clinical usage/Effect on growth rate. Effect on adrenal function. Development of infection diseases by diseases type.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated with Pulmicort Turbuhaler for the first time due to bronchial asthma and children of >= 5 years and < 15 years old age at the start of study treatment
排除标准
- 未提供
结局指标
主要结局
Adverse event incidence. We will investigate, intensively, development of Adverse Drug Reactions, especially infections. Detection of Adverse Drug Reactions unexpected from the Precautions for use.
时间窗: Two years
Effects on growth rate and the adrenal cortical function, development of infections
时间窗: Two years
次要结局
- Variation of the asthma control status (total of JPAC：Japanese Pediatric Asthma Control Program score) from the baseline score.(Two years)
- Variation of the parental questionnaire (score by factor) from the baseline score.(Two years)
研究者
研究点 (1)
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