NCT00513487已完成不适用
Assessment of the Effects of Multiple Nasal Antigen Challenges With Dust Mite Allergen on Local and Systemic Allergic Inflammation and Bronchoreactivity in Subjects With Allergic Rhinitis Sensitive to House Dust Mite - a Feasibility and Site Evaluation Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Total nasal symptom score recorded at baseline, and at pre-challenge,15 mins, 30 mins,and at 1,2,3,4,8 hours
研究概览
简要总结
This study will evaluate whether multiple nasal antigen challenges with dust mite allergen produces increases in nasal symptoms and local allergic inflammatory cells in the nose and the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy non-smoking subjects with a history of allergic rhinitis consistent with dust mite allergy showing
- •A positive skin prick test to dust mite at or within the 12 months before study start
- •Demonstrate symptomatic worsening after graded nasal allergen challenge
排除标准
- •Subjects found to be very sensitive to house dust mites (if the skin prick test produces a wheal of mean with a diameter greater than 11 mm).
- •Presence of any respiratory disease other than a history of mild stable asthma not requiring regular treatment.
- •Any known contraindications for methacholine challenge testing
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Total nasal symptom score recorded at baseline, and at pre-challenge,15 mins, 30 mins,and at 1,2,3,4,8 hours
时间窗: throughout the study
次要结局
- Peak nasal inspiratory flow at time points of total nasal symptom score. Mechanistic markers during challenge days. Exhaled nitric oxide,forced expiratory vol in 1 second & airway resistance at baseline, first & last day(throughout the study)
研究者
研究点 (1)
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