NCT01130064已完成2 期
A Multi-center, Randomized, Double Blind, Placebo-controlled, 'add-on' Study to Investigate the Efficacy and Safety of 24 Weeks Intravenous Treatment With QAX576 in Patients (≥18-75 Years) With Persistent Asthma Not Adequately Controlled With Inhaled Corticosteroids and Long Acting β2-agonists
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 259
- 试验地点
- 1
- 主要终点
- Asthma Control Questionnaire
研究概览
简要总结
The purpose of this study is to investigate the efficacy of 24 weeks intravenous treatment with QAX576 in patients with persistent asthma not adequately controlled with inhaled corticosteroids and long acting beta2-agonists.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients
- •Female patients must be surgically sterilized or postmenopausal
- •Male patients must use two forms of contraception
- •Body mass index must be between 18 and 39 kg/m2
- •Diagnosis of asthma for at least one year, which is not adequately controlled by inhaled corticosteroids and long acting beta-2 agonists
排除标准
- •Smoking history >10 pack-years
- •Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
- •Patients who have experienced a severe asthma attack/exacerbation requiring systemic corticosteroids or an increase in maintenance doses, within 6 weeks of screening
- •Patients who have had a respiratory tract infection within 6 weeks prior to screening
- •History of schistosomiasis, within 6 months of screening, or traveling to a country endemic with schistosomiasis within 6 months of completing the study
研究组 & 干预措施
QAX576
Experimental
QAX576
干预措施: QAX576 (Biological)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Asthma Control Questionnaire
时间窗: 24 weeks
次要结局
- Incidence rate of clinically significant asthma exacerbations(24 weeks)
研究者
研究点 (1)
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