NCT00657891已完成4 期
The Effect of Xolair (Omalizumab) 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
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- To determine if Xolair (omalizumab) inhibits basophil leukotriene secretion & to compare this with its inhibition of histamine release. We will also compare this inhibition in basophils stimulated with allergen vs anti-IgE vs calcium ionophore.
研究概览
简要总结
We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood tests will be done in a test tube to see if they react differently before and after treatment. The blood cells will be mixed with to whatever the person is allergic.
详细描述
Must be allergic-asthma with IgE between 30 and 700 IU/ml.
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
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2 year history of ragweed allergic rhinitis
- •positive skin prick tests to ragweed >5 mm wheal diameter
- •serum 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 1 week
- •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
Placebo Injection
干预措施: Placebo (Drug)
2
Experimental
Xolair at 0.016 mg/kg/IgE(iu/ml)/4 wks
干预措施: Omalizumab (Drug)
结局指标
主要结局
To determine if Xolair (omalizumab) inhibits basophil leukotriene secretion & to compare this with its inhibition of histamine release. We will also compare this inhibition in basophils stimulated with allergen vs anti-IgE vs calcium ionophore.
时间窗: 1 year
次要结局
- To determine the effect of Xolair (omalizumab) on IL-4 &vIL-13 secretion. To compare the effect of Xolair on IL-4 vs IL-13 secretion from basophils stimulated with allergen, anti-IgE & calcium ionophore (ionomycin).(1 year)
研究者
研究点 (1)
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