EUCTR2017-001799-41-Outside-EU/EEA进行中（未招募）1 期
A 26-week randomized, double-blind, placebo-controlled, multi-center study to evaluate the effect of omalizumab on markers of asthma impairment in patients with persistent allergic asthma
ovartis Pharmaceutical Corporation0 个研究点目标入组 266 人开始时间: 2017年8月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 266
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
- •Inclusion Criteria:
- •Total Asthma Control Test (ACT) score of =19 plus at least one of the following in the 4 weeks preceding visit 1, on average:
- •?Symptoms > 2 days/week
- •?Night-time awakenings =1 time/week
- •?Short-acting beta2-agonist (SABA) use for symptom control >2 days/week forced expiratory volume in 1 second (FEV1) = 80% predicted
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 19
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 239
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •Exclusion Criteria:
- •History of intubation for asthma.
- •An asthma exacerbation requiring treatment with systemic steroids within 4 weeks of screening (Visit 1).
- •Less than 3 months of stable maintenance oral corticosteroid therapy for asthma
研究者
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