Effect of Nasaleze on the Early Reaction to Nasal Challenge With Allergen
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent
研究概览
简要总结
The objectives of this protocol are:
- to confirm the inhibitory effect of Nasaleze on the immediate response to nasal challenge with antigen, and
- to show that inhibition of the immediate response to nasal challenge with antigen by Nasaleze inhibits subsequent inflammatory events.
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
- 未提供
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.
- •FEV1<80% of predicted at screening for subjects with history of mild asthma.
研究组 & 干预措施
Nasaleze spray
Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge
干预措施: Nasaleze Spray (Drug)
Nasaleze spray
Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge
干预措施: Allergen (Biological)
Placebo spray
Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge
干预措施: Placebo spray (Other)
Placebo spray
Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge
干预措施: Allergen (Biological)
结局指标
主要结局
Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent
时间窗: Day 2 after one week pretreatment with Nasaleze or placebo.
Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms.
次要结局
未报告次要终点