Effects of Anti-IL5 Biological Treatments of Total Blood IgE Levels in Severe Asthmatic Patients: Real-life Retrospective Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 8
- 主要终点
- IgE levels in mepolizumab group
研究概览
简要总结
Real-life, observational, retrospective, multicenter study to evaluate the effects of anti-IL5 biological treatments on blood total IgE Levels in atopic patients with severe eosinophilic asthma.
详细描述
Severe asthma, i.e. asthma that is not controlled despite maximal optimized therapy and/or that worsens when high dose treatment is decreased (GINA guidelines - available at https://ginasthma.or), is a major unmet medical need. Major advances in the management of severe asthma occurred in the past few years due to the new targeted biological therapies. Mepolizumab and Benralizumab are humanized monoclonal antibodies able to block interleukin (IL)-5 and the receptor for IL-5, respectively. These biological treatments block the eosinophilic driven inflammation. The effects of these treatments on an other key effector molecule of the T2-immune response, i.e. IgE, is virtually unknown.
To explore this issue, we set up a real life, observational, retrospective, multicenter study. The study will enroll patients with severe eosinophilic asthma already treated with Mepolizumab or Benralizumab. The following variable will be collected before the the biological treatment and at 4±2 months after the initiation of the pharmacological regimen:
- demographic data
- age of onset of asthma
- smoking habit
- concomitant pharmacological regimens
- number of asthma exacerbations since last visit
- concomitant diseases (particularly gastroesophageal reflux, nasal polyposis, atopic dermatitis, obesity, anxiety-depressive syndrome).
- White Blood Cell Count and Differential (and in particular the levels of total leucocytes, lymphocytes, eosinophils and basophils)
- Lung function tests (spirometry)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe eosinophilic asthma (according to GINA guideline - available at https://ginasthma.org)
- •patients treated with monoclonal antibody anti IL-5 (Mepolizumab) or with IL-5 anti-receptor monoclonal antibody (Benralizumab).
- •stable asthma (free from asthma exacerbation for at least 8 weeks)
排除标准
- •asthma exacerbation in last 8 weeks
- •patients treated for COPD
结局指标
主要结局
IgE levels in mepolizumab group
时间窗: 4±2 months
To evaluate total IgE levels (kU/l) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months after initiation of anti-IL5 monoclonal antibody Mepolizumab
次要结局
- Eosinophils (%) in Benralizumab group(4±2 months)
- Total leucocytes in mepolizumab group(4±2 months)
- Eosinophils (number) in mepolizumab group(4±2 months)
- Eosinophils (%) in mepolizumab group(4±2 months)
- Basophils (number) in mepolizumab group(4±2 months)
- Basophils (%) in mepolizumab group(4±2 months)
- lymphocytes (number) in mepolizumab group(4±2 months)
- Lymphocytes (%) in mepolizumab group(4±2 months)
- IgE levels in Benralizumab group(4±2 months)
- Total leucocytes in Benralizumab group(4±2 months)
- Eosinophils (number) in Benralizumab group(4±2 months)
- Basophils (number) in Benralizumab group(4±2 months)
- Basophils (%) in Benralizumab group(4±2 months)
- Lymphocytes (number) in Benralizumab group(4±2 months)
- Lymphocites (%) in Benralizumab group(4±2 months)
- respiratory function (FEV1 - liter) in Mepolizumab group(4±2 months)
- respiratory function (FEV1 - %) in Mepolizumab group(4±2 months)
- respiratory function (vital capacity - liter) in Mepolizumab group(4±2 months)
- respiratory function (vital capacity - %) in Mepolizumab group(4±2 months)
- respiratory function (forced vital capacity - liter) in Mepolizumab group(4±2 months)
- respiratory function (forced vital capacity - % predicted) in Mepolizumab group(4±2 months)
- respiratory function (FEV1/FVC ratio) in Mepolizumab group(4±2 months)
- respiratory function (FEV1/VC ratio) in Mepolizumab group(4±2 months)
- respiratory function (FEV1 - %) in Benralizumab group(4±2 months)
- respiratory function (FEV1 - lier) in Benralizumab group(4±2 months)
- respiratory function (FVC - liter) in Benralizumab group(4±2 months)
- respiratory function (FVC - %) in Benralizumab group(4±2 months)
- respiratory function (VC - liter) in Benralizumab group(4±2 months)
- respiratory function (VC - %) in Benralizumab group(4±2 months)
- respiratory function (FEV1/FVC ratio) in Benralizumab group(4±2 months)
- respiratory function (FEV1/VC ratio) in Benralizumab group(4±2 months)
- Fractional exhaled nitric oxigen (FeNO) in Mepozumab group(4±2 months)
- Fractional exhaled nitric oxigen (FeNO) in Benralizumab group(4±2 months)
- Asthma control test in Mepolizumab group(4±2 months)
- Asthma control test in Benralizumab group(4±2 months)
- correlation between eosinophils and total IgE(4±2 months)
- correlation between total IgE and lung function(4±2 months)
- correlation between total IgE and asthma control(4±2 months)
研究者
Alberto Papi, MD
Head of Respiratory Unit
Università degli Studi di Ferrara