Mepolizumab: Real World Evidence Study for the Treatment of Severe Eosinophilic Asthma in Greece
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Reduction of annual exacerbation rate in patients with severe eosinophilic asthma in treatment with mepolizumab
研究概览
简要总结
A prospective multi-centre, non-interventional observational study, that will be conducted in several centers in Greece for a 2-year time period (completion date December 2020), to describe patient characteristics, medical history, and the clinical benefit of mepolizumab in patients with severe eosinophilic asthma newly initiated to the drug.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with uncontrolled severe eosinophilic asthma placed under treatment with mepolizumab, i.e. in patients with peripheral blood eosinophils ≥300 cells/μL at any measurement in the previous year or ≥150 cells/μL in a recent measurement, with poor symptom control and increased number of exacerbations (2 or more) despite optimal treatment with high doses of inhaled corticosteroids and β2 stimulants
排除标准
- •Patient refusal to participate in the study
结局指标
主要结局
Reduction of annual exacerbation rate in patients with severe eosinophilic asthma in treatment with mepolizumab
时间窗: 2 years
Reduction of the clinical significant exacerbations in comparison to the year before the initiation of treatment with mepolizumab. A clinical significant exacerbation is an exacerbation that requires treatment as follows: increase of dose of oral corticosteroids intake
Quality of life improvement in patients with severe eosinophilic asthma receiving mepolizumab as it measured by Asthma Control Test (ACT)
时间窗: 2 years
ACT is a 5-point scale that assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. An ACT score 19 or less means that asthma is not well controlled
次要结局
未报告次要终点
研究者
Stylianos Loukides
Assistant Professor
Attikon Hospital