Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma

Novartis1 个研究点分布在 1 个国家目标入组 133 人开始时间: 2003年11月1日最近更新: 2011年10月25日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 133
试验地点: 1
主要终点: Safety of omalizumab

研究概览研究设计入排标准结局指标研究者研究点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 48 weeks in adult patients with moderate to severe bronchial asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

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

Safety of omalizumab

次要结局

Pulmonary function parameters measured by spirometer
Morning and evening peak expiratory flow (PEF)
Symptoms score, treatment score, activities of daily living score, nighttime sleep score, and asthma score

研究者

发起方

Novartis

申办方类型

Industry

研究点 (1)

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