Observational Retrospective Study to Characterise and Assess Clinical Outcomes of Patients Receiving Benralizumab After Marketing Approval in Spain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Total IgE
研究概览
简要总结
Primary Objectives:
- To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma in Spain who received at least one dose of Benralizumab, after its marketing authorization
- To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after the index date (benralizumab initiation)
This is a descriptive, observational, multi-centre, longitudinal, retrospective cohort study in 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 in Spain, on January 1st 2019.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age ≥18 years)
- •Diagnosis of severe eosinophilic asthma requiring stable treatment of high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller.
- •Patients with at least 12-month data available before index date (starting benralizumab treatment)
- •Patients with at least 3-month electronic medical records data available from first benralizumab dose ("index date")
- •Informed consent signed.
排除标准
- •Patients who received benralizumab in a clinicaltrial, during the observation period.
结局指标
主要结局
Total IgE
时间窗: Baseline period
Gender
时间窗: Up to 12 months (Baseline period)
Specifically, at the time of taking the first dose of study drug
Concomitant asthma medications
时间窗: Baseline period
Smoking Habits
时间窗: Up to 12 months (Baseline period)
Age at athma diagnosis
时间窗: Up to 12 months (Baseline period)
Severe asthma exacerbations
时间窗: In the previous 12 months
Number of diagnostic/therapeutic tests per patient
时间窗: Baseline period
Asthma related only
Number of allergy tests per patient
时间窗: Baseline period
Age
时间窗: Up to 12 months (Baseline period)
Specifically, at the time of taking the first dose of study drug
Number of patients with positive Prick test
时间窗: Baseline period
FeNo
时间窗: Baseline period
ACT (or ACQ) score
时间窗: Baseline period
Asthma Control Test (ACT), the scores range from 5 to 25, with higher scores reflecting greater asthma control. Asthma Control Questionnaire (ACQ), the total score range between 0 (well controlled asthma) and 6 (extremely poorly controlled)
Physician office visits
时间窗: Baseline period
Split by primary care and specialist (asthma related)
Number of conventional radiology procedures per patient
时间窗: Baseline period
Number of spirometries per patient
时间窗: Baseline period
Number of magnetic resonance imaging procedures per patient
时间窗: Baseline period
Blood eosinophils count
时间窗: Baseline period
Lung function (FEV1 and FVC)
时间窗: Baseline period
AQLQ score
时间窗: Baseline period
Asthma Quality of Life Questionnaire (AQLQ), it scores from 1 (minimum) to 7 (maximum) where the higher the score, the better the quality of life is
Key comorbidities
时间窗: Baseline period
Emergency room visits
时间窗: Baseline period
OCS-related comorbidities
时间窗: Baseline period
Number of laboratory tests per patient
时间窗: Baseline period
Asthma treatment
时间窗: Up to 24 months (study duration)
Including previous biologic treatment, type of treatment and reasons for discontinuation or switching
Hospitalisations
时间窗: Baseline period
Number and duration
Number of computed axial tomographies per patient
时间窗: Baseline period
次要结局
未报告次要终点