NCT00575861已完成4 期
Evaluation of Additive Effects of Zileuton to Advair on Total Exhaled, Bronchial, and Alveolar Nitric Oxide in Asthmatics
Gelb, Arthur F., M.D.1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2005年9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
- 19
- 试验地点
- 1
- 主要终点
- nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide
研究概览
简要总结
Evaluate the additive role of zileuton 600mg qid to clinically stable asthmatics on Advair 250/50 bid. Since asthma is an endogenous inflammatory disease there usually is increased total exhaled, bronchial and alveolar nitric oxide which are markers of eosinophilic driven pathways of inflammation. The addition of zileuton which is a leukotriene synthesis inhibitor by itself or together with inhaled corticosteroids should reduce nitric oxide gas exchange.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-smoking
- •Moderate to severe persistent asthmatics
- •Clinically stable X 6 weeks on Advair 250/50 bid for at least 12 months
排除标准
- •No leukotriene synthesis inhibitors or receptor antagonists for 6 weeks
研究组 & 干预措施
1
Active Comparator
Advair 250/50 (baseline) fluticasone/salmeterol 250/50
干预措施: zileuton (Drug)
结局指标
主要结局
nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide
时间窗: 2 hr to 1 month
次要结局
- expiratory spirometry and asthma symptom Juniper score(2 hr to 1 month)
研究者
研究点 (1)
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