NCT07218172已完成不适用
Characterization and Clinical Outcomes of Severe Asthma Patients in Israel Treated With Benralizumab (SAIL-B)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Asthma related characteristics
研究概览
简要总结
A retrospective, observational, one arm, single country study, using the computerized database of Maccabi Health Services (MHS). The study will include adult patients who initiated benralizumab treatment for SEA between January 1, 2019, and March 31, 2024. The study population will include both biologic-naive and biologic-experienced patients. Patients will be followed from 12 months before the index date until the earliest of the following dates: switching, death, leaving MHS or end of the study follow-up period (June 30, 2024).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An authorization from MHS drugs authorization center for benralizumab, with a diagnosis of asthma (ICD-9 code 493.X and the corresponding internal MHS diagnosis codes for SA). Having an authorization indicates that patients have severe eosinophilic asthma and fulfil the GINA definition of severe asthma as well as additional local reimbursement criteria.
- •At least one purchase of benralizumab for the first time between January 1 2019 and March 31
- •Age ≥18 years on the index date.
- •MHS members for at least 12 months before the index date.
排除标准
- •Patients who received benralizumab for indication other than asthma according to MHS drugs authorization center.
- •- currently or recently included in a clinical trial according to the ICD-9 diagnosis code V70.7) and the corresponding internal MHS codes
结局指标
主要结局
Asthma related characteristics
时间窗: Jan2019-Mar2024
Number of exacerbations (baseline)
次要结局
- Asthma related measure(Jan2019-Mar2024)
研究者
研究点 (1)
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