Benralizumab Patient Access Programme Study: Retrospective, Observational Study in UK Severe Asthma Centres to Describe Patient Characteristics, Treatment Patterns and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 276
- 试验地点
- 8
- 主要终点
- Baseline annual exacerbation rate
研究概览
简要总结
Retrospective secondary data collection observational chart review study. Data collection and analysis will be performed on a cohort of patients who have previously been enrolled on the BPAP. Approximately 300 patients taking part in the BPAP between April 2018 and November 2019 and who meet the eligibility criteria will be recruited to participate in the study.
Data for each participant in the study will be obtained retrospectively with a focus on obtaining data at baseline (12 months prior to first benralizumab dose or at first assessment in the severe asthma center if <12 months), Index date (date of first benralizumab dose) and at least up to 24 months after index date.
Primary Objectives
- To describe baseline demographic and clinical characteristics of severe eosinophilic asthma patients enrolled in the BPAP
- To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after benralizumab initiation
Secondary Objectives:
- To describe clinical outcomes after initiation of benralizumab therapy in severe eosinophilic asthma patients treated with benralizumab at 12 and 24 months
- To describe patients' adherence to benralizumab, persistence and discontinuation rates and reasons for discontinuation at 12 and 24 months
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
- •Patients enrolled on the BPAP between April 2018 and November 2019
- •Patients who have at least 1 benralizumab injection and with at least 3 months followup data from the time of enrolment into the BPAP
- •Patients initiated on benralizumab outside of the BPAP by October 30,
- •Where CRO employees conduct the data extraction, patients must be able and willing to give informed consent to participate in the study
排除标准
- •Currently receiving benralizumab or any other biologic drug for the treatment of asthma in a clinical trial
- •Refusal or inability to provide informed consent where the CRO will be collecting the data
结局指标
主要结局
Baseline annual exacerbation rate
时间窗: -12 to 0 months
Baseline frequency and annualized rate of asthma exacerbations by severity levels
Maintenance OCS dose during baseline
时间窗: -12 to 0 months
Maintenance OCS: frequency of patients on mOCS, dosage (for patients on mOCS), annualized cumulative dose
次要结局
- FEV1(24 months)
- Annualised exacerbation rate (AER)(24 months)
- AQLQ(S)+12(24 months)
- ACQ-6(24 months)
- Eosinophil count(24 months)
- mOCS dose(24 months)
- Treatment persistence(24 months)
- Adherence to scheduled injections(24 months)