The Effect of Salmeterol on Eosinophil (EOS) Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge
研究概览
简要总结
This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or the combination treatment with fluticasone and salmeterol, is associated with a greater number of sputum eosinophils following antigen challenge and, under these circumstances, the migrating peripheral blood eosinophils are less adherent.
详细描述
An antigen challenge is when a participant inhales either cat, ragweed, or dust dander in increasing concentrations until their lung function drops 15 or 20 percent.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-55 years of age
- •history of asthma symptoms for the previous 6 months
- •Forced Expiratory Value (FEV1) >75% of predicted
- •positive prick skin test to cat, house dust mite or ragweed
排除标准
- •history of life threatening asthma or anaphylaxis
- •current smoker
- •pregnant or breast-feeding
- •evidence of an upper respiratory infection within 4 weeks of screening
研究组 & 干预措施
Placebo Diskus
Placebo comparator
干预措施: Placebo (Drug)
Salmeterol Diskus 50 mcg twice per day
Salmeterol Diskus 50 mcg twice per day
干预措施: salmeterol (Drug)
Placebo diskus, fluticasone
placebo diskus, fluticasone MDI 88 mcg twice per day
干预措施: Fluticasone (Drug)
Salmeterol, Fluticasone
Salmeterol diskus 50 mcg BID, fluticasone MDI 88 mcg twice per day
干预措施: salmeterol (Drug)
Salmeterol, Fluticasone
Salmeterol diskus 50 mcg BID, fluticasone MDI 88 mcg twice per day
干预措施: Fluticasone (Drug)
结局指标
主要结局
Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge
时间窗: Eosinophils are measured 24 hours after the subject has an antigen challenge
Sputum samples were collected from the participants. Cell counts were made from these samples after treatment with 0.1% dithiothreitol. Percentage of eosinophils were reported. Time frame measurement was 24 hours after the subject had an antigen challenge.
次要结局
未报告次要终点