NCT00598104撤回1 期
A Randomized, Double-blinded, Placebo Controlled, Parallel Group, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Doses of QAX576 in Moderate Persistent Allergic Asthmatics Following Inhaled Corticosteroid Withdrawal
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Novartis
- 主要终点
- - Forced expiratory volume in 1 second (FEV1)at baseline and until study completion - Levels of eosinophils in sputum
研究概览
简要总结
This study will evaluate the safety and efficacy of QAX576 against asthma attacks in adults with moderate persistent allergic 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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of asthma attacks
- •Taking inhaled corticosteroids
- •Non-smoking
排除标准
- •Women of child-bearing potential
- •History of respiratory disease other than asthma
- •History of severe allergy to food or drugs
- •Previous use of monoclonal antibodies
- •Very low or high body weight
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1
Experimental
干预措施: QAX576 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
- Forced expiratory volume in 1 second (FEV1)at baseline and until study completion - Levels of eosinophils in sputum
时间窗: Throughout the study
次要结局
- - Three doses of QAX576 on time to treatment failure, plasma IL-13 levels and immunogenicity in asthmatics - Sputum biomarkers(Throughout the study)
研究者
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