A 16-week Treatment, Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel-group Study to Assess the Effect of Omalizumab on the Expression of FcεRI Receptors of Blood Basophils and Dendritic Cells in Patients With Severe Persistent Non-atopic Asthma, Uncontrolled Despite Optimal Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils
研究概览
简要总结
This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe persistent asthma with the following characteristics:
- •Uncontrolled according to Global Initiative for Asthma (GINA) 2007 guidelines and at least 2 exacerbations having required systemic corticosteroid and/or at least 1 hospitalization or emergency room visit in the past year.
- •Treated with high-dose inhaled corticosteroid (i.e. > 1,000 µg beclometasone dipropionate equivalent per day) plus inhaled long-acting β2 agonist (with or without maintenance oral corticosteroid).
- •Non-atopic, i.e. negative blood multiallergic testing and negative Aspergillus-specific IgE-radio allergosorbent blood test and negative skin prick tests to a battery of common aeroallergens
排除标准
- •Current smokers or smoking history stopped for less than 3 years or > 10 pack years.
- •Asthma exacerbation during the 4 weeks prior to randomization.
- •Active lung disease other than non-atopic asthma.
- •Patients with an active cancer, a suspicion of cancer or any history of cancer with less than 5 disease free years.
- •Pregnant or nursing (lactating) women.
- •Treatment with omalizumab.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Omalizumab
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
干预措施: omalizumab (Drug)
Placebo
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils
时间窗: Baseline and 16 weeks
Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of blood basophils (mean fluorescence intensity(MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.
Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells
时间窗: Baseline and 16 weeks
Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of dendritic cells (mean fluorescence intensity (MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.
次要结局
- Change in Fractional Exhaled Nitric Oxide (FeNO)(Baseline and 4, 8, 12 and 16 weeks)
- Change From Baseline in Induced Sputum Eosinophil Count(Baseline and 16 weeks)
- Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)(Baseline and 16 weeks)
- Change From Baseline in Nasal Symptom Global Score and Individual Components(Baseline and 16 weeks)
- Physician and Patient Global Evaluation of Treatment Effectiveness(16 weeks)
- Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks(Baseline and 16 weeks)
- Number of Patients With at Least One Asthma-related Event Over 16 Weeks(16 weeks)