EUCTR2013-003269-33-HU进行中（未招募）1 期
A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects with Inadequately Controlled, Severe Asthma
MedImmune LLC(a wholly owned subsidiary of AstraZeneca PLC, One MedImmune Way, Gaithersburg, Maryland, 20878, USA )0 个研究点目标入组 552 人开始时间: 2013年11月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 552
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age and weight range as defined in the protocol.
- •Documented Physician-diagnosed asthma in line with the protocol requirements.
- •Subjects must have received a physician-prescribed asthma controller
- •regimen as outlined in the protocol.
- •Able to meet the pulmonary function requirements and other defined asthma metrics/measures as outlined in the study protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 510
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •Established diagnosis of occupational asthma.
- •Current smokers or subjects with a smoking history of = 10 pack years.
- •Any concomitant respiratory disease, including acute upper or lower respiratory infections.
- •Known history of active tuberculosis (TB).
- •Receipt of any marketed or investigational biologic agent within 4 months or 5 half lives prior to Visit 1 (Week 5), whichever is longer.
研究者
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