ACTRN12621000113853已完成未知
A single-site cross-sectional cohort study with longitudinal follow-up to investigate the effect of mepolizumab treatment on homeostatic and induced eosinophils, eosinophil extracellular traps, mast cells and basophils in people with severe eosinophilic asthma
niversity of Newcastle0 个研究点目标入组 80 人开始时间: 2021年2月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Able to provide informed written consent
- •2.Adults (18 years or older) with doctor diagnosed severe asthma based on Global Initiative For Asthma (GINA) 2019 guidelines and PBS eligibility criteria for initiation of treatment of severe asthma with mepolizumab as follows:
- •a.Evidence or documented evidence of asthma defined by:
- •i.Forced expiratory volume (FEV1) reversibility greater than or equal to 12%, and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), OR
- •ii.Airway hyper-responsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, OR
- •iii.Peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days, OR
- •iv.Diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma
- •b.Asthma is uncontrolled* or not well-controlled^ despite adherence with optimized moderate to high dose inhaled corticosteroid-long-acting beta-2 agonist (ICS-LABA)# therapy and treatment of contributory factors, or that worsens when high dose treatment is decreased.
- •c.*Uncontrolled asthma includes one or both of the following:
- •i.Poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma)
- •ii.Exacerbations (1 or more in prior year) requiring oral corticosteroids (OCS), or serious exacerbations (1 or more in prior year) requiring hospitalization
- •^Not well-controlled asthma is defined by ACQ5 greater than or equal to 1.0 during study screening or at baseline visit (see O’Byrne PM, Reddel HK, Eriksson G et al. Measuring asthma control: a comparison of three classification systems. Eur Resp J. 2010;36:269-276 and Juniper EF, Bousquet J et al. Identifying ‘well-controlled’ and ‘not well-controlled’ asthma using the Asthma Control Questionnaire. Resp Med. 2006;100(4):616-621.)
- •d.# For GINA definition of moderate to high dose ICS see (https://ginasthma.org/wp-content/uploads/2019/04/GINA-2019-main-Pocket-Guide-wms.pdf)
- •3.Stable disease, defined by lack of respiratory infection, exacerbation of asthma or alteration of maintenance asthma medication dose in prior 4 weeks to visit.
排除标准
- •- Pregnancy/breastfeeding
- •- Participants currently receiving or having received in past 6 months treatment with benralizumab or omalizumab.
- •- No exacerbation of asthma in prior 4 weeks at screening.
研究者
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