ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab in a Real Life Setting: an Observational rEtrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- key features at benralizumab treatment start)
研究概览
简要总结
This is an observational, Italian multi-center, retrospective cohort study with enrollment visit on patients suffering from severe eosinophilic asthma who started benralizumab in the Sampling Program or as per normal clinical practice in Italy.
详细描述
A retrospective cohort study design involving secondary data collection was chosen to appropriately address the primary objective in a relatively short period of time after enrollment phase initiation: in fact, since the Italian Sampling Program on benralizumab was active since July 2018, clinical data on patients exposed to benralizumab are already available. No treatments will be administered per protocol requirement, but instead according to normal clinical practice; since benralizumab first administration occurs before inclusion in the study (as per chosen study design), the decision to include the patient in the study is clearly separated from the prescription of benralizumab, in accordance with the observational nature of the study. In order to be eligible for the study, for each patient, the index date shall be at least 3 months prior to enrollment.
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
- •Adult patients (age ≥18 years) at the start of benralizumab treatment within the sampling program or per clinical practice ("index date").
- •Patients with severe eosinophilic asthma requiring a stable treatment of high doses of inhaled corticosteroids and a long acting β2 agonist ± additional asthma controller (according to clinician's judgment).
- •Patients who started benralizumab and received at least one injection at least 3 months before enrollment, either within the sampling program or as per routine clinical practice.
- •Patients who signed the informed consent and privacy form at enrollment visit.
- •Patients with available hospital medical chart since the start of benralizumab treatment within the sampling program or per clinical practice ("index date").
排除标准
- •Patients who, during the observation period, received benralizumab in a clinical experimental trial.
- •Patients who, during the observation period, participated in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.
结局指标
主要结局
key features at benralizumab treatment start)
时间窗: At baseline
Total IgE and eosinophils count in peripheral blood as measured at index date Lung function assessments Presence of comorbidities Previous severe exacerbations in the 12 months before index date. Previous treatments with biologics for asthma before index date. Maintenance asthma treatment(s) ongoing at index date.
次要结局
- biologic treatments during the observation period(at 16 weeks)
- IgE and eosinophils count during benralizumab treatment, and changes over time with respect to benralizumab treatment start(at 16 weeks)
- patient's adherence to benralizumab treatment(at 16 weeks)
- severe exacerbations during benralizumab treatment(at 16 weeks)
- lung function parameters during benralizumab treatment, and changes over time with respect to benralizumab treatment start(at 16 weeks)
- benralizumab discontinuation(at 16 weeks)
- ICS and OCS change during benralizumab treatment(at 16 weeks)
- patients' asthma control level and quality of life at benralizumab treatment start, during the observation period, and changes over time with respect to benralizumab treatment start(at 16 weeks)
- healthcare resource utilization during benralizumab treatment(at 16 weeks)