Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Tryptase Level From Baseline to Post-antigen Challenge
研究概览
简要总结
The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females between 18 and 45 years of age.
- •History of grass and/or ragweed allergic rhinitis.
- •Positive skin test to grass and/or ragweed antigen.
- •Positive response to screening nasal challenge.
排除标准
- •Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- •Pregnant or lactating women.
- •Upper respiratory infection within 14 days of study start.
研究组 & 干预措施
Veramyst, then Placebo
fluticasone furoate (Veramyst) nasal spray once daily for a week, then one week washout period followed by placebo nasal spray once daily for a week
干预措施: fluticasone furoate (Drug)
Veramyst, then Placebo
fluticasone furoate (Veramyst) nasal spray once daily for a week, then one week washout period followed by placebo nasal spray once daily for a week
干预措施: Placebo (Drug)
Placebo, then Veramyst
placebo nasal spray once daily for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily for a week
干预措施: fluticasone furoate (Drug)
Placebo, then Veramyst
placebo nasal spray once daily for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily for a week
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Tryptase Level From Baseline to Post-antigen Challenge
时间窗: After one week of treatment wtih veramyst or placebo
Tryptase levels (mcg/L) were measured from nasal lavages
次要结局
- Total Eye Symptom Scores After Antigen Challenge(After one week of treatment wtih veramyst or placebo)
研究者
Robert Naclerio
MD
University of Chicago