NCT01006161撤回2 期
Proof-of-Concept and Dose Range-Finding Study of SCH 527123 in Subjects With Severe Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Severe asthma exacerbations, pulmonary function test data, and a change in symptoms
研究概览
简要总结
Given the strong inhibition of SCH 527123 on neutrophil migration to sites of inflammation, there is a theoretical reason for its use in patients with severe asthma where neutrophils are thought to play a significant role in the pathophysiology of the disease.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have severe asthma, be at least 18 to less than or equal to 70 years of age, of either sex, and any race.
排除标准
- •Subject who has been diagnosed with COPD or any other clinically relevant lung disease, other than asthma (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis).
研究组 & 干预措施
Low dose SCH 527123
Experimental
干预措施: SCH 527123 (Drug)
Medium dose SCH 527123
Experimental
干预措施: SCH 527123 (Drug)
High dose SCH 527123
Experimental
干预措施: SCH 527123 (Drug)
Placebo
Placebo Comparator
干预措施: SCH 527123 (Drug)
结局指标
主要结局
Severe asthma exacerbations, pulmonary function test data, and a change in symptoms
时间窗: Measured over the duration of the trial.
次要结局
未报告次要终点
研究者
相似试验
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