Interaction Between Benralizumab and Basophils in Eosinophilic Asthma. Discovering a New Role of an Old Asthma Player: BASEAS STUDY (Basophils in Eosinophilic Asthma)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The fold changes of IL-5R expression in basophils
研究概览
简要总结
In this study, investigators want to evaluation of the impact of benralizumab (Fasenra®, Astra Zeneca) on different cell populations, including basophils and innate lymphoid cells, and several biomarkers, such as miRNAs, cadena α dek receptor pra la interleukin % (IL5Rα) and soluble IL5Rα in patients with severe eosinophilic asthma. For this, basophil and innate cells type 2 (ILC2) populations will be monitored in different point-time of treatment: 8 week (V1), 6 months (V2) and 1 year (V3) in blood and sputum samples. Also, follow-up IL5Rα expression on a cell surface of eosinophils, basophils and ILC2 from peripheral blood and sputum of patients treated with or or without benralizumab. Determination of IL5Rα levels will be performed by flow cytometry
详细描述
For this:
- Investigators will monitor basophil miRNAs changes with benralizumab analyzing miRNAS profile of isolated basophil before and after benralizumab treatment.
- Also, in vitro characterization of benralizumab effects on functionality of human basophils (isolated from allergic asthmatic patients) and human cell line KU812, measuring apoptosis, activation, degranulation and histamine release will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.It is mandatory that all patients can comprehend the study requirements and provide informed consent for their participation in MEGA.
- •Adult people (≥ 18 and ≤ 80 years old) with eosinophilic severe asthma requiring high-dose inhaled corticosteroids plus long-acting beta agonists (with or without long-acting muscarinic antagonist or Montelukast or oral corticosteroids)
- •Benralizumab treatment approved.
- •.Patients with allergic asthma (prick test or RAST positive).
排除标准
- •Patients with continuous OCS treatment
- •Patients with Immunosuppressive drugs
- •Patients with primary or secondary immune deficiency,
- •Patients with chronic or/and concomitant disease, presence of severe systemic disease or cancer,
- •Patients with possible infestation by parasites.
- •Patients with other acute or chronic active lung disorders Patients with significant psychiatric disorders
- •Patients with biological treatment will be excludes for group B
结局指标
主要结局
The fold changes of IL-5R expression in basophils
时间窗: From 1 to 12 months
The fold changes of IL-5R expression in basophils after 8 week, 6 months and 1 year of benralizumab treatmen
Fold changes in number of basophils
时间窗: From 1 to 12 months
Fold changes in number of basophils after 8 week, 6 months and 1 year of benralizumab treatment (Fasenra®, Astra Zeneca) in blood and sputum in patients with severe eosinophilic asthma
Fold changes in number of innate inmmune cells
时间窗: From 1 to 12 months
Fold changes in number of innate immune cells s after 8 week, 6 months and 1 year of benralizumab treatment (Fasenra®, Astra Zeneca) in blood and sputum in patients with severe eosinophilic asthma
The fold changes of f IL-5R expression in innate lymphoid cells
时间窗: From 1 to 12 months
The fold changes of f IL-5R expression in innate lymphoid cells after 8 week, 6 months and 1 year of benralizumab treatment
次要结局
- Fold changes of miRNAs profile in basophils(From 6 to 18)
- Effect of benralizumab in KU812 activation(From 12 to 24 months)
- Effect of benralizumab in basophil apoptosis(From 12 to 24 months)
- Effect of benralizumab in KU812 apoptosis(From 12 to 24 months)
- Fold changes of serum IL-5R(Fromm 6 to 12)
- Effect of benralizumab in basophil activation(From 12 to 24 months)
- Effect of benralizumab in basophil degranulation(From 12 to 24 months)
- Effect of benralizumab in KU812 degranulation(From 12 to 24 months)