Retrospective, Observational Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps Treated by FASENRA®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 273
- 试验地点
- 1
- 主要终点
- Baseline demographics, clinical characteristics, and background treatments, as well as PROs for asthma control and HRQoL, asthma exacerbation, and healthcare resource utilization.
研究概览
简要总结
The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.
详细描述
In light of the increasing importance of comorbidities in driving choice for biologics in severe asthma there is a knowledge gap to understand SEA patients with comorbid NP for whom the decision to start biologics was based on the presence of severe, uncontrolled asthma. This retrospective, observational study will describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current or previous treatment with benralizumab for SEA
- •Physician-confirmed diagnosis and evaluation of NP using NPS and/or SNOT-22 before and after first benralizumab injection
- •Patients who have follow-up period of at least 5 months from first benralizumab injection or at least 4 consecutive injections of benralizumab
- •Able to provide signed informed consent (if required based on local guidelines)
排除标准
- •Patient on any other biologic during the 12 months prior to treatment with benralizumab
- •Previously or currently receiving any biologics for the treatment of asthma or NP in a clinical trial. This exclusion criteria does not apply to patients that received biologic treatment from openlabel one-arm interventional studies that provided biologic treatment as part of standard of care (according to approved labelling in that country).
结局指标
主要结局
Baseline demographics, clinical characteristics, and background treatments, as well as PROs for asthma control and HRQoL, asthma exacerbation, and healthcare resource utilization.
时间窗: At or up to 12 months prior to first benralizumab dose.
To describe baseline demographics, clinical characteristics, and background treatments, as well as PROs (patient-reported outcomes) for asthma control and HRQoL(health-related quality of life), asthma exacerbation, and healthcare resource utilization.
次要结局
- Total NPS(Up to 12 months prior to and up to 12 months from first benralizumab dose.)
- SNOT-22 total score(Up to 12 months prior to and up to 12 months from first benralizumab dose.)
- Overall SCS use. SCS use for asthma only. SCS use for NP only(Up to 12 months from first benralizumab dose.)
- Asthma Clinical outcomes.(Up to 12 months from first benralizumab dose.)
- NP surgery type and/or procedure(Up to 12 months from first benralizumab dose.)
- Repeated or revision surgery for NP(Up to 12 months from first benralizumab dose.)
- Time to NP surgery(Up to 12 months from first benralizumab dose.)
- NP surgery complications(Up to 12 months from first benralizumab dose.)