A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lyophilized and Aged Liquid Omalizumab in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 主要终点
- Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)
研究概览
简要总结
This was a multicenter, randomized, double-blind, parallel-group, three-arm, placebo-controlled study designed to demonstrate the efficacy of two different formulations of omalizumab compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult subjects with mild allergic 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form
- •Meet criteria for the diagnosis of allergic asthma
- •Be between the ages of 18 to 65 years
- •Have a normal chest X-ray within 2 years of screening
排除标准
- •Need daily controller medication for asthma
- •History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin)
- •Have a documented medical history of anaphylaxis
- •Have lung disease other than mild allergic asthma
- •Have taken other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer
- •Are unable or unwilling to comply with study procedures and visits
- •Are pregnant or lactating
- •Have significant medical illness other than asthma, including malignancies, parasitic infections, immune system disorders, and thrombocytopenia
- •Have been treated with omalizumab within 12 months prior to screening
- •Currently smoke or have a history of smoking more than 10 pack-years
- •Have a history of drug or alcohol abuse, which, in the judgment of the investigator, may put the subject at risk for being unable to participate fully in the study for the duration of the study
研究组 & 干预措施
1
干预措施: omalizumab (Drug)
2
干预措施: omalizumab (Drug)
3
干预措施: placebo (Drug)
结局指标
主要结局
Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)
时间窗: From baseline to Week 16
The primary analysis included two tests: a test for superiority of the lyophilized formulation of omalizumab compared with placebo in the change of allergen concentration and a test for the superiority of the aged liquid omalizumab compared with placebo. The difference for the change in the allergen concentration between the lyophilized formulation of omalizumab and placebo, and between the aged liquid omalizumab and placebo were assessed by the exact Wilcoxon-Mann-Whitney test.
次要结局
- Ratio of the Allergen Forced Expiratory Volume at One Second (FEV1) Two-point Slope at the Week 16 Allergen Challenge to the Allergen FEV1 Two-point Slope at the Baseline Allergen Challenge(From baseline to Week 16)