NCT00828061已完成1 期
A Randomized Clinical Trial to Study the Effects of Single Dose of Corticosteroid on Response to Nasal Allergen Challenge in Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration
研究概览
简要总结
This study will investigate whether changes in inflammatory mediators produced by the nose after exposure to an allergen can be used to evaluate the anti-inflammatory effects of novel drugs for the treatment of allergic asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
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
- •Patient is allergic to Timothy grass pollen
- •Female patients have a negative pregnancy test and agree to use birth control throughout the study
- •Male patients agree to use birth control throughout the study
- •Patient has been a nonsmoker for at least 6 months
- •Patient agrees to avoid the use of aspirin and other Non-steroidal anti-inflammatory drugs (NSAIDs) throughout study
排除标准
- •Patient is breastfeeding
- •Patient has any respiratory disease other than mild stable asthma that does not require treatment
- •Patient consumes more than 3 alcoholic beverages per day
- •Patient consumes more than 6 caffeinated beverages per day
- •Patient has had major surgery or has donated or lost 1 unit of blood within 4 weeks of screening
- •Patient has severe allergies
研究组 & 干预措施
A
Placebo Comparator
placebo
干预措施: Placebo (Drug)
B
Active Comparator
10 mg prednisone
干预措施: prednisone (Drug)
C
Active Comparator
25 mg prednisone
干预措施: prednisone (Drug)
结局指标
主要结局
Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration
时间窗: Baseline and Hour 8 post nasal allergen challenge
Comparison of the Change in Allergen-induced Interleukin 5 (IL-5) as Measured in Nasal Exudates After a Single Dose of Low or High Dose of Oral Prednisone Relative to Placebo
次要结局
- Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils(Baseline and Hour 8 post nasal allergen challenge)
研究者
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