The Efficacy of Mepolizumab in Patients With Severe Eosinophilic Asthma Treated in Poland. The Real-life Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Asthma Exacerbations During 52 Weeks Preceding Treatment Initiation (as Assessed at Baseline) and at the 24th and 52nd Week of the Treatment
研究概览
简要总结
This study is aimed at evaluation of the efficacy of mepolizumab 100 mg subcutaneously (SC) every 4 weeks in patients with severe eosinophilic asthma who have been treated for at least 12 months in several Polish allergy/asthma centres under the same protocol. Target population to be recruited has been set at 130 subjects from at least 6 asthma centers throughout the country. Data on demographics and asthma status will be collected using questionnaires at 3 time-points: pre-mepolizumab (pre-MEPO), after 24 weeks of mepolizumab (MEPO) and after 1 year of MEPO administration (some of the outcomes will be observed every 4 weeks). Primary endpoints will include:
- Asthma exacerbations measured at qualification for the treatment (in the period of previous 52 weeks) and at the 24th and 52nd week of the treatment.
- Oral Corticosteroids use dose (documented at qualification for the treatment and at the 24th and 52nd week of the treatment).
详细描述
This study is aimed at evaluation of the efficacy of mepolizumab 100 mg SC every 4 weeks in patients with severe eosinophilic asthma who have been treated for at least 12 months in several Polish allergy/asthma centres under the same protocol. Retrospective multicentre observational study will involve 130 patients with severe eosinophilic asthma (SEA) who have been treated in six Severe Asthma Treatment Centres (SATCs) in Poland. In each SATC all data available in the program questionnaires will be transferred to the Study Data Sheet (questionnaire), and will be send to the study coordinator within 5 months from the study beginning The start-up meeting including partners from all centres involved will be organized to discuss the study protocol and to unify data collection The evaluation parameters (exacerbations rate, OCS dose) will be analysed at least at three time points: pre-MEPO, after 24 weeks of MEPO and after 1 year of MEPO administration (some of the outcomes will be observed every 4 weeks, for the details see 'study endpoints' section).
In addition the following parameters which are available in patients' records will be analysed:
- 5-item asthma control questionnaire (ACQ-5) score (measured at qualification for the treatment and every 4 weeks thereafter)
- Asthma quality of life questionnaire (AQLQ) score (measured at qualification for the treatment and every 4 weeks thereafter)
- Pre-bronchodilator FEV1 (measured at qualification for the treatment and every 4 weeks thereafter)
Research activities will include:
- collecting raw data from the clinical centres (paper version) and constructing a raw dataset (digital version),
- data cleaning, computation of variables,
- statistical analysis typical for pre-post study design (the statistical analysis will be outsourced to the specialized private institute).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •* The availability of the complete data
- •Duration of treatment with mepolizumab: ≥ 52 weeks
- •Satisfying the Polish drug programme inclusion criteria:
- •Before treatment with mepolizumab (BSAT inclusion criteria):
- •High doses of inhaled corticosteroids (ICS) + one other controlling medication (i.e. LABA)
- •≥2 exacerbations in the previous year
- •≥350 eosinophil cells/microliter (µl) in the peripheral blood at the time of qualification or in the previous year
- •Pre-bronchodilator FEV1 < 80%
排除标准
- •* Duration of treatment with mepolizumab < 52 weeks
- •Lack of complete data
研究组 & 干预措施
Severe asthma patients treated with mepolizumab
Patients having received mepolizumab 100 mg SC every 4 weeks for at least 12 months in six severe-asthma clinics in Poland between December 2017 and December 2019
干预措施: Mepolizumab given SC 100mg every 4 weeks between Dec 2017 and Dec 2019 (Biological)
结局指标
主要结局
Asthma Exacerbations During 52 Weeks Preceding Treatment Initiation (as Assessed at Baseline) and at the 24th and 52nd Week of the Treatment
时间窗: Baseline (before mepolizumab initiation); week 24; week 52
Data as transferred from the treatment program questionnaires to the Study Data Sheet. Asthma exacerbations, defined according to the Polish drug programme, is the worsening in asthma requiring (1) use of systemic corticosteroids or (2) increase in dose of OCS for more than 3 days in case of patients who are chronically treated with OCS.
Number Patients Requiring Treatment With Oral Corticosteroids (OCS) at a Chronic Basis (Documented at Qualification for the Treatment and at the 24th and 52nd Week of the Treatment)
时间窗: Baseline (before mepolizumab initiation); week 24; week 52
Data as transferred from the treatment program questionnaires to the Study Data Sheet
次要结局
- ACQ-5 (Asthma Control Questionnaire 5-item) Score(Baseline (before mepolizumab initiation); week 24; week 52)
- AQLQ (Asthma Quality of Life Questionnaire) Score(Baseline (before mepolizumab initiation); week 24; week 52)
- Pre-bronchodilator FEV1(Baseline (before mepolizumab initiation); week 24; week 52)
- Blood Eosinophil Counts(Baseline (before mepolizumab initiation); week 24; week 52)