NCT00252135已完成不适用
An Epidemiologic Study of Xolair (Omalizumab): Evaluating Clinical Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma (EXCELS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,023
研究概览
简要总结
This study is a multicenter, prospective, observational cohort study of ~5000 Xolair-treated and ~2500 non-Xolair-treated patients with moderate to severe persistent asthma and a positive skin test or in vitro reactivity to an aeroallergen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent document (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
- •≥12 years of age
- •Physician diagnosis of moderate to severe persistent asthma
- •Evidence or history of positive skin test or in vitro reactivity to an aeroallergen
- •Willingness to participate fully for the duration of the study (5 years)
- •For patients in the Xolair-treated cohort, have received at least one dose of Xolair therapy at the time of enrollment
排除标准
- •Contraindication to Xolair therapy (e.g., patients who experienced a severe hypersensitivity reaction to Xolair)
- •Acute asthma exacerbation within the previous 2 weeks of screening requiring any of the following: initiation of systemic corticosteroids, increased doses of systemic corticosteroids from baseline, doubling of inhaled corticosteroids, emergency room visit, or hospitalization
- •Acute flare of significant systemic disease (e.g., infection, hematologic, renal, hepatic, cardiovascular diseases, or gastrointestinal diseases), or a recent hospitalization because of their disease within the previous 2 months
- •Use of an experimental drug within 30 days prior to study screening
- •Diagnosis of cystic fibrosis
- •For patients in the non-Xolair-treated cohort, any prior treatment with Xolair
研究者
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