A26-wk,Randomized,Dble-Blinded,Parallel-Grp,Placebo-Controlled,Multi-Centered Study to Eval.the Effect of Xolair(Omalizumab)on Improving the Tolerability of Spec.Immunotherapy in Patients With at Least Mod. Persistent Allergic Asthma Inadequately Controlled w/Inhaled Corticosteroids
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Evaluate the effect of omalizumab on systemic allergic reactions to specific immunotherapy (SIT) in patients with persistent allergic asthma who require treatment with inhaled steroids
研究概览
简要总结
In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab(administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).
详细描述
Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma. This study is designed to give omalizumab 13 weeks prior to administering rapid build up of specific allergy shot, with an overlap of omalizumab and cluster therapy for 3 weeks. The cluster therapy will take 4 week to complete with maintenance dosage lasting an additional 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis and history of moderate persistent allergic asthma
- •body weight >/= 20kg and </= 150kg
- •Total serum IgE >/= 30 and </= 700IU/mL
- •on a stable asthma treatment including corticosteroids for the preceding 4 weeks
- •non smoker for at least 1 year prior to visit 1
排除标准
- •patients with severe asthma
- •history of immunotherapy to any allergen within the past 3 years
- •history of anaphylactic allergic reaction
- •upper respiratory tract infection
研究组 & 干预措施
1
Placebo will be compared to Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
干预措施: Xolair (Drug)
2
Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
干预措施: Xolair (Drug)
结局指标
主要结局
Evaluate the effect of omalizumab on systemic allergic reactions to specific immunotherapy (SIT) in patients with persistent allergic asthma who require treatment with inhaled steroids
时间窗: 2005-2007
次要结局
未报告次要终点