NCT00453778已完成4 期
A Study to Investigate the Effect of Inhaled Fluticasone Propionate on the Bronchial Responsiveness to Leukotriene D4 in Asthmatics Patients
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- LTD4 PC20
研究概览
简要总结
Investigate if asthmatics treated with FLIXOTIDE (FP) 500 mcg BID during 14 days get reduced bronchial reactivity after inhalation of Leukotriene D4. Two 14 days treatment periods where patients received FP 500 MCG BID and placebo. Washout at least 21 days between treatments. Bronchial challenge with methacholine and Leukotriene D4 were performed before the start of each treatment period and on treatment days 13 and 14 respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed history of asthma
- •Non smoker last two years
- •< 5 pack years
- •FEV1 >70% of predicted
- •Mild and stable asthma
- •Only using short acting b2-agonist as rescue for the last 4 weeks
- •Have a history of atopy.
排除标准
- •Any significant respiratory disease, other than asthma
- •Subjects with seasonal asthma may not be included if they are in their season
- •Use of oral or inhaled glucocorticosteroid for the last 3 months and long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and antileukotrienes within two weeks
- •Upper or lower RTI within 6 weeks
- •Evidence of any disease that in the investigators mind would affect the results of the study
- •Participating in another study within 4 weeks
- •Females who are pregnant, intend to be or who are lactating
- •Methacholine PD20 > 454mcg
- •Negative scin prick test
结局指标
主要结局
LTD4 PC20
次要结局
- Shift in methacholine PD20
研究者
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