CTRI/2013/03/003478尚未招募4 期
Multicenter, openlabel, noncomparative, clinical decision basedpostmarketing surveillance (PMS) study forEvaluation of efficAcy and Safety of Xolair (Omalizumab)in IgE mediated Asthma in Pediatric patients - EASE-P
ovartis Healthcare Private limited0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Male or Female, 6 and 18 years of age
- •2. With inadequately controlled moderate to severe persistent allergic asthma (GINA Stage IV)
- •a. A positive Skin Prick Test or RAAST Test to greater than or equal to 1periennial aeroallergen, or strong clinical
- •b. IgE levels greater than or equal to 30 less er than or equal to 1500 IU per mL
- •c. Continuous treatment with high dose ICS plus LABA 2 severe exacerbations per year
- •d. Require more than 2 courses of oral corticosteroids in year
- •e. Regular disruptive nocturnal or daytime symptoms as per GINA Stage IV
排除标准
- •1.Patients that have been treated with Xolair in the past 18 months.
- •2. Severe medical condition(s) that in the view of the physician prohibits participation in the study
- •e.g. severe renal or hepatic impairment
- •3. Known hypersensitivity to Xoalir (Omalizumab) or any of the components in the formulation
研究者
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