NCT00639691已完成4 期
A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab)in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Serious Adverse Events from first visit until end of study
研究概览
简要总结
This study has the objective of providing compassionate use access to omalizumab (Xolair) and to evaluate the Safety of Xolair in subjects with severe allergic asthma who remain symptomatic despite optimal therapy according to GINA step 4 treatment guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female, ≥ 6years of age;
- •who have a diagnosis of allergic asthma ≥ 1 year duration according to American Thoracic Society (ATS) criteria;
- •severe persistent allergic asthma who remain symptomatic despite optimal therapy (as per Canadian Asthma Consensus Report (1999));
- •Subjects having successfully completed one of the following protocols: CIGE025A011E3, CIGE025A2425, CIGE025AIA05;
- •elevated immunoglobin E levels
排除标准
- •significant systemic disease
- •pregnancy or lactation
- •an active lung disease other than allergic asthma (eg: cystic fibrosis, bronchiestasis);
- •history of food or drug related severe anaphylactoid or anaphylactic reaction(s);
- •current treatment with warfarin (Coumadin®), immunomodulatory therapy (e.g., methotrexate, gold, cyclosporine), or antiplatelet therapy.
结局指标
主要结局
Serious Adverse Events from first visit until end of study
次要结局
- To evaluate reasons for premature discontinuation.
- All adverse events, duration of study participation.
研究者
研究点 (1)
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