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临床试验/NCT00233584
NCT00233584已完成不适用

A Study to Evaluate the Feasibility of a Treatment Algorithm in Newly Diagnosed Asthmatic Children. An Open Follow-up to Asthma Prevention in Infants/Young Children (PAC)

AstraZeneca1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2001年7月最近更新:
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
400
试验地点
1
主要终点
Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps.

研究概览

简要总结

This prospective study will evaluate the feasibility of the defined decision tree for the treatment of asthmatic young children. Children who develop episode (=3 consecutive days) of any troublesome lower respiratory symptoms are treated according to a strictly pre-defined multi-steps treatment algorithm until the age of 6 years.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children form the COPSAC/PAC study with episodes of troublesome respiratory symptoms. Episodes are defined as 3 consecutive days of any troublesome lower respiratory symptoms.

排除标准

  • Differential diagnoses including at least a chest x-ray and sweat test.

结局指标

主要结局

Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps.

Efficacy - development of lung function.

次要结局

  • Acceptability of the treatment algorithm by the parents.
  • Growth rate and BMD.
  • Exhaled nitrogen Oxide, bronchohyperresponsiveness.

研究者

发起方
AstraZeneca
申办方类型
Industry

研究点 (1)

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