NCT00522782已完成4 期
Phase IV Study of the Effect of Nebulized Budesonide on Exhaled Nitric Oxide in Children, Four to Six Years of Age, With Asthma
AAADRS Clinical Research Center1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Exhaled breath nitric oxide pre- to post treatment
研究概览
简要总结
To study the improvement in airway inflammation in children with asthma non-invasively with exhaled breath NO, a marker of inflammation, after therapy with nebulized budesonide as 0.5mg daily.
详细描述
Comparisons will be made before and after 2 week therapy of nebulized budesonide in children not on prior anti-inflammatory medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthma diagnosis previously for 6 months
- •Past asthma medication without change for previous 6 months
- •Increased NO levels and ability to perform maneuver
- •ICF signed by parents
排除标准
- •Systemic steroids in past 60 days,inhaled/nebulized steroids in past 4 weeks
- •Hospitalization within 3 months
- •Upper or lower airways active infection or cigarette smoke direct exposure
- •Use of other asthma medications other than bronchodilators one month prior and during the trial
- •Noncompliance
研究组 & 干预措施
A
Active Comparator
Nebulized budesonide
干预措施: Nebulized Budesonide (Drug)
A
Active Comparator
Nebulized budesonide
干预措施: Nitric Oxide Analyzer (Device)
结局指标
主要结局
Exhaled breath nitric oxide pre- to post treatment
时间窗: two weeks
次要结局
- Spirometry with peak flow measurements and daily diary scores(two weeks)
研究者
研究点 (1)
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