Observational Retrospective Study to Characterise Patients Receiving Benralizumab in the Framework of an Individualized Access Program in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Sex
研究概览
简要总结
Observational, retrospective study in adults (≥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 investigator were candidates to receive benralizumab in the individualized access program approved by national health authorities.
Primary Objective: To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma who participated in the individualized access program approved in Spain and received at least one dose of benralizumab.
Secondary Objectives: To describe clinical outcomes in severe eosinophilic asthma patients who received at least three doses of benralizumab in the individualized access program.
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)
- •Diagnosis of severe eosinophilic asthma requiring stable treatment of high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller
- •Received at least one dose of benralizumab during the individualized access program period (March-December of 2018)
- •Informed consent signed
排除标准
- •Patients enrolled in a clinical trial who received benralizumab during the same period of the individualized access program
- •Refuse to sign the informed consent
结局指标
主要结局
Sex
时间窗: Up to 32 weeks
Male, Female
Body Mass Index (BMI)
时间窗: Up to 32 weeks
Weight and height will be combined to report BMI in kg/m\^2
Age at onset of asthma diagnosis
时间窗: Up to 32 weeks
Age (years)
Age
时间窗: Up to 32 weeks
Age (years)
Smoking status
时间窗: Up to 32 weeks
Current smoker, Ex-smoker, Never smoker
Comorbidities
时间窗: Up to 32 weeks
Multiple response (binomial): allergies, nasal polyposis, rhinitis, GERD, atopic dermatitis, condition related with chronic OCS use, other eosinophilic driven diseases
Hospitalizations
时间窗: Up to 32 weeks
Number of hospitalizations
Unscheduled visits
时间窗: Up to 32 weeks
Number of unscheduled visits
Severe exacerbations
时间窗: Up to 32 weeks
Severe exacerbations in past 12 months: number and severity
Emergency room (ER) visits
时间窗: Up to 32 weeks
Number of ER visits
ACT
时间窗: Up to 32 weeks
ACT questionnaire score
Blood eosinophils
时间窗: Up to 32 weeks
Blood eosinophils count (cells/microL)
miniAQLQ
时间窗: Up to 32 weeks
miniAQLQ questionnaire score
次要结局
- Incidence of severe exacerbations(Up to 32 weeks)