临床试验/NCT00232050

NCT00232050已完成3 期

Study of Omalizumab in Moderate to Severe Bronchial Asthma

Novartis0 个研究点目标入组 327 人开始时间: 2002年10月1日最近更新: 2011年10月25日

适应症

相关药物

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 327
主要终点: Morning peak expiratory flow (PEF) at baseline and end of treatment.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult patients with moderate to severe bronchial asthma.

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

入排标准

年龄范围: 20 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Allergic asthma patients
•Inadequately controlled patients

排除标准

•- History of severe anaphylactoid or anaphylactic reactions
•Previous treatment with omalizumab
•History of cancer or cancer
•Other protocol-defined exclusion criteria may apply

结局指标

主要结局

Morning peak expiratory flow (PEF) at baseline and end of treatment.

次要结局

Pulmonary function parameters measured by spirometer
Frequency of rescue medication use
Symptom score
Activities of daily living score
Nighttime sleep score

研究者

发起方

申办方类型

Industry

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