NCT01603277已完成2 期
A Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 70
- 主要终点
- Change in Percent Predicted FEV1 at Week 24
研究概览
简要总结
This study will evaluate the safety, tolerability and efficacy of a single dose level of KB003 in subjects with inadequately controlled 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of asthma established for at least 2 years
- •Symptomatic asthma as defined by the Juniper Asthma Control Questionnaire
- •Symptomatic asthma despite stable treatment with inhaled corticosteroids fluticasone or budesonide, or other corticosteroids, for at least 12 weeks
- •Currently receiving inhaled long-acting beta agonist (LABA) or previously documented LABA intolerability or lack of responsiveness
- •At least 2 exacerbations (no more than 6) in the previous 12 months that required systemic corticosteroids or at least a doubling of daily oral dose
排除标准
- •Acute asthma worsening (requiring emergency room visit, hospitalization, urgent care, physician visit, or change in asthma medications) or lower respiratory tract infection requiring the use of antibiotics, within 4 weeks prior to Screening Visit.
- •History of life-threatening asthma with admission to the intensive care unit requiring the use of mechanical ventilation within the past 12 months
- •Use of any immunosuppressive or immunomodulatory agents within 12 weeks or an investigational agent within 4 weeks prior to Screening Visit
- •History of any cardiovascular, neurological, hepatic, or renal condition
- •History of smoking within the past 12 months
结局指标
主要结局
Change in Percent Predicted FEV1 at Week 24
时间窗: Baseline to Week 24
次要结局
- To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate(Week 24)
- To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF)(Week 24)
- To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments(Week 24)
研究者
研究点 (70)
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