NCT00673218Unknown4 期
The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Basophil histamine release
研究概览
简要总结
If you are allergic to ragweed, and not taking certain medications, you will be asked to have blood drawn. We will perform experiments on your blood cells.
详细描述
Adult ragweed allergic subjects will have blood drawn. Basophils will be enriched and stimulated with allergen and controls. Supernatants from these stimulations will be assayed for cytokines and histamine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 19 to 50
- •At least 2 year history of ragweed allergic rhinitis
- •Positive skin prick tests to ragweed >5 mm wheal diameter
- •IgE <700 iU/m
排除标准
- •Use of prohibited medications (e.g. antihistamine in past 7 days and topical or oral corticosteroids in past 1 month, beta-agonist or theophylline for 2 days.
- •History of immunotherapy in the past 2 years
- •Exposure to Omalizumab in the past 2 years
- •Clinically significant non-allergic or perennial rhinitis to avoid mediator release due to environmental allergens
- •Asthma other than mild intermittent
- •Women of childbearing potential who are not on an accepted form of birth control, as well as women who are breastfeeding
- •Known sensitivity to study drug Xolair
- •Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- •Patients with a previous history of cancer
- •Use of any other investigational agent in the last 30 days
研究组 & 干预措施
1
Placebo Comparator
Saline injection to match active
干预措施: Placebo (Drug)
Treatment
Experimental
Active treatment with Xolair 150 to 375 mg is administered SC every 2 or 4 weeks
干预措施: Xolair (Drug)
结局指标
主要结局
Basophil histamine release
时间窗: After 4 weeks treatment
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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