Betreat (Xaloc1) Benralizumab Study: Retrospective, Observational Study in Portuguese Hospitals 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
- 74
- 试验地点
- 15
- 主要终点
- Baseline demographic and clinical characteristics of severe eosinophilic asthma patients treated with benralizumab
研究概览
简要总结
Benralizumab is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β2-agonists. It has been reimbursed in Portugal as an add-on therapy since May 2019. In order of this, there is crucial need in Portugal to provide key real-word evidence on benralizumab therapy.
详细描述
This is a real-world retrospective, multicentric, observational study, utilizing secondary data collection from medical records of adults patients (≥18 years) with severe asthma (maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2) and eosinophilic phenotype, who, at the discretion of the physician, received benralizumab accordingly to the clinical practice, in the period after the marketing authorization of benralizumab.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patients with severe asthma treated with benralizumab, who had their first benralizumab dose between July 2019 and October 2020
- •Patients who have at least 1 benralizumab injection and with at least 3 months follow-up data from the first injection.
- •Give voluntary signed informed consent
排除标准
- •Currently receiving benralizumab or any other biologic drug for the treatment of asthma in a clinical trial
结局指标
主要结局
Baseline demographic and clinical characteristics of severe eosinophilic asthma patients treated with benralizumab
时间窗: Baseline/Index date
Demographic: Gender, age, BMI, smoking history Clinical: age of asthma diagnosis, ACT score, CARAT score, blood eosinophil count, FeNO, Lung function, FVC, Reversibility of FEV1, Total IgE in peripheral blood, Skin PRICK test
Background treatment patterns of severe eosinophilic asthma patients at baseline and after benralizumab initiation and treatment duration with benralizumab
时间窗: Baseline, 3, 6, 12 and 24 months
Medication history: asthma treatment type, doses and treatment duration Proportion of patients with biologic discontinued and reason for discontinuation Benralizumab treatment patterns: benralizumab treatment duration, frequency of benralizumab treatment discontinuation, time to treatment discontinuation and frequency and type of concurrent respiratory medication
次要结局
- Clinical outcomes after initiation of benralizumab theraoy in severe eosinophilic asthma patients(Baseline, 3, 6, 12 and 24 months)
- Asthma-related Healthcare resource utilization (HCRU) among severe eosinophilic asthma patients before and after initiation of benralizumab therapy(Baseline, 3, 6, 12 and 24 months)