A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical ASP-1001 (Contrast Media Formulation) in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (NAC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Sneezing Symptom
研究概览
简要总结
The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen.
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 Days 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females between 18 and 55 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 or sinusitis within 14 days of study start.
- •Use of nasal steroids, antihistamines in the last 2 weeks.
- •FEV1<80% of predicted at screening for subjects with history of mild asthma
- •current smokers or recent ex-smokers
- •Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
研究组 & 干预措施
1
Topical ASP-1001
干预措施: ASP-1001 nasal spray (Drug)
2
Placebo for Topical ASP-1001
干预措施: Placebo for ASP-1001 (Drug)
结局指标
主要结局
Change in Sneezing Symptom
时间窗: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.
Change in Runny Nose Symptom
时间窗: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.
Change in Stuffy Nose Symptom
时间窗: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.
Change in Itching Symptom
时间窗: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.
次要结局
- Nasal Peak Inspiratory Flow Measurements(15 minutes after diluent challenge and 15 minutes after each antigen challenge)
- Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment(15 minutes prior to treatment and 15 minutes post antigen challenges)
研究者
Robert Naclerio
Professor
University of Chicago