NCT01064726已完成1 期
A Double Blind (3rd Party Open), 3-Way Crossover Study To Explore The Reproducibility Of Inflammatory Markers After Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis (Out Of Season) And The Effect Of A Single Dose Of Ibuprofen Or Fluticasone Propionate On The Allergen Response.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Nasal inflammatory markers
研究概览
简要总结
After a nasal allergen challenge it should be possible to measure markers of inflammation that may be useful to assess the properties of future drugs. If these markers are reproducible and impacted by the study drugs they could be useful for future drug development.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with seasonal allergic rhinitis (out of season).
- •Sensitive to ragweed skin prick test and screening nasal allergen challenge.
排除标准
- •Subjects with significant concomitant diseases.
- •Subjects with symptoms of allergic rhinitis in 2 weeks prior to screening.
- •Female subjects that are pregnant or nursing. Subjects with hypersensitivity to study drugs or allergen challenge.
研究组 & 干预措施
Ibuprofen
Experimental
干预措施: Ibuprofen (Drug)
Fluticasone propionate
Experimental
干预措施: Fluticasone propionate (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Nasal inflammatory markers
时间窗: 8h 45 min post dose
Acoustic rhinometry
时间窗: 8h 45 min post dose
Nasal symptom scores
时间窗: 8h 45 min post dose
次要结局
- Spirometry(8h 45 min post dose)
研究者
研究点 (1)
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