Type and Mechanisms of Residual Asthma Exacerbations in Patients Treated With Mepolizumab
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of eosinophilic vs non-eosinophilic remaining exacerbation during the treatment period
研究概览
简要总结
This will be a two-year prospective study to characterize the nature of the remaining asthma exacerbations in patients treated with mepolizumab. Participants will be assessed every six months from pre- until two years of treatment in addition to whenever they experience an exacerbation of asthma during the study period. During these visits, various clinical, physiological and inflammatory outcomes will be assessed.
详细描述
Before initiation of mepolizumab, a recording of patient's demographics, clinical, physiological and inflammatory features will be recorded. All subjects will be reassessed for the above measures at 6, 12, 18 and 24 months.
In addition to the above visits, patients will be assessed every time they experience either moderate or severe exacerbation of asthma over the treatment period.
Based on the percentage of sputum eosinophils and neutrophils, the type of inflammatory exacerbation will be determined
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With a proven diagnosis of severe asthma as defined by the Canadian Thoracic Society
- •Eligible for mepolizumab treatment
- •Able and willing to sign the informed consent form
排除标准
- •Any respiratory disease apart from asthma
- •Confounding comorbidities sur as eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome
研究组 & 干预措施
Study population
Subjects with severe asthma treated with mepolizumab
干预措施: Mepolizumab (Drug)
结局指标
主要结局
Proportion of eosinophilic vs non-eosinophilic remaining exacerbation during the treatment period
时间窗: Between baseline and month 24
Eosinophilic exacerbation defined as \>=3% sputum eosinophils. Ratio of eosinophilic vs non eosinophilic asthma exacerbation
次要结局
- Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) at 24 months(Baseline and month 24)
- Change from baseline in post-bronchodilator FEV1/forced vital capacity (FVC) ratio at 24 months(Baseline and month 24)
- Change from baseline in percentage of sputum neutrophils(Baseline and month 24)
- Change from baseline in asthma control on the Asthma Control Questionnaire (ACQ-5) at 24 months(Baseline and month 24)
- Change from baseline in fraction of exhaled nitric oxide (FeNO) levels at 24 months(Baseline and month 24)
- Change from baseline in percentage of sputum eosinophils at 24 months(Baseline and month 24)
研究者
Andréanne Côté
Respirologist-intensivist
Laval University