Effect of Anti-interleukin 5 (IL5) Therapy on Sputum Cells and Cytokines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 22
- 主要终点
- Airway inflammation
研究概览
简要总结
22 asthmatics, in which mepolizumab was to be started, gave permission for inclusion and were followed up prospectively. Clinical and lung functional data, sputum analyses and cytokine measurements were analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FEV1 < 80% in the last 12 months
- •use of high dose inhaled corticosteroids (ICS) in combination with other additional medication or continuous use of oral corticosteroids (OCS)
- •at least 2 exacerbations in the last 12 months
- •at least 300 blood eosinophils/µl once in the last 12 months and at the time of inclusion
- •Anti-IL5 treatment prescribed by the physician
排除标准
- •Not completing all visits
研究组 & 干预措施
Asthmatics
Patients receive anti-IL5 treatment as part of their prescribed routine. Immunological and clinical parameters will be evaluated at the start of the treatment and after 6 months of treatment
干预措施: Mepolizumab Injection [Nucala] (Drug)
结局指标
主要结局
Airway inflammation
时间窗: Day 1 and after 6 months
Bronchial airway inflammation. Differential cell count will be performed on sputum samples, determining eosinophilic (\>3% eosinophils, \<61% neutrophils), neutrophilic (\<3% eosinophils and \>61% neutrophils), pauci-granulocytic (\<3% eosinophils and \<61% neutrophils) and mixed granulocytic airway inflammation (\>3% eosinophils and \>61% neutrophils).
Change in Forced Expiratory Volume in 1 seconds (FEV1)
时间窗: Day 1 and after 6 months
The forced expiratory Volume in 1 second will be measured using spirometry
次要结局
- Change in asthma control(Day 1 and after 6 months)
- Cytokine pattern in the airways(Day 1 and after 6 months)
- Cytokine pattern in the bloodstream(Day 1 and after 6 months)
- Biomarkers for airway inflammation(Day 1 and after 6 months)
研究者
Tatjana Decaesteker
Principal Investigator
KU Leuven