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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 271
- 试验地点
- 50
- 主要终点
- Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment
研究概览
简要总结
This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Other protocol-defined inclusion/exclusion criteria applied
研究组 & 干预措施
Omalizumab
The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
干预措施: Omalizumab (Drug)
Placebo
Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment
时间窗: Baseline and 24 weeks
The Asthma Control Test (ACT) is a validated tool to assess overall asthma control over the last 4 weeks in patients aged \>= 12 years old. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.
次要结局
- Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks(24 weeks)