A Multicentre Single Arm Observational Prospective Study to Assess Demographic Characteristics Burden of Disease PRO's in Uncontrolled, Severe Eosinophilic Asthma Patients Aged 18y or Older and Qualifying for Treatment With Benralizumab in BE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- change in patient-reported asthma related symptoms
研究概览
简要总结
This study aims to assess health and quality of life outcomes in patients treated with benralizumab, within a Belgian Real-World setting. To prove the clinical value of benralizumab in a Real-World setting, the study will document the effect of benralizumab within a time frame of 112 weeks after initiation of treatment.
详细描述
The aim and objective of this single arm, prospective observational study is to provide supporting RWE on the symptom relief of asthma patients qualified for benralizumab therapy in Belgium. The PRO measures consist of the Asthma Control Questionnaire (ACQ 6) as well as Patient Global Impression of Change and Severity (PGI-C and PGI-S), healthcare resource utilization (HCRU) and treatment satisfaction (TSQM-9). In addition change in daily OCS use and rate of exacerbations after initiation of benralizumab in real-world setting will be assessed
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18 years or older with physician's confirmed diagnosis of severe, uncontrolled asthma
- •Asthma requiring high dose inhaled corticosteroid plus long-acting β adrenoceptor agonist as maintenance treatment
- •A decreased lung function (FEV1 <80%), demonstrated by spirometry in the 12 months before initiation of treatment
- •Patients need to fulfil one of the criteria:
- •at least 2 hospitalizations or ER treatments for severe asthma during last 12 months, or
- •at least 2 asthma exacerbations during last 12 months (worsening of asthma with need of systemic corticotherapy for at least 3 days for non cortico-dependent patients, and/or an ER visit and or a hospitalization),
- •or cortico-dependent (at least 6 months treatment with OCS at a daily dose of 4 mg or more of methylprednisolone or 5 mg or more of prednisolone for adults)
- •Peripheral blood eosinophil count ≥300cells/μl at initiation of benralizumab treatment and in the year before.
- •Obtained reimbursement for treatment with benralizumab
- •Provision of signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation in the study.
- •Patients must be able and willing to read and comprehend written instructions and comprehend and complete the questionnaires required by the protocol.
- •Benralizumab naïve and have not previously received benralizumab prior to the start of this study.
排除标准
- •Patients currently enrolled in an interventional clinical study in parallel (i.e. have not completed) including those with biologic treatment, will be excluded from the study except for patients who are in parallel documented in the Belgian Severe Asthma Registry (BSAR).
- •Concurrent biologics for asthma are not allowed except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment. Acceptable wash-out periods for other asthma biologics:
- •≥30 days from last dose of previous biologic
- •Patients with other documented lung disease other than asthma and not within reimbursed label.
结局指标
主要结局
change in patient-reported asthma related symptoms
时间窗: up to 6 months after initiation of benralizumab
assessed with the Asthma Control Questionnaire (ACQ-6). The primary outcome variable (asthma control responder) is defined as a patient who had an at least (≥) 0.5-unit improvement in ACQ-6 score.
次要结局
- Rate of exacerbations after initiation of benralizumab in a real-world setting(up to 112 weeks after initiation of benralizumab)
- change in daily OCS use following initiation of benralizumab in real-world setting(up to 112 weeks after initiation of benralizumab)
- change in asthma status in a real-world setting(up to 112 weeks after initiation of benralizumab)
- change of disease severity in a real-world setting(up to 8 weeks after initiation of benralizumab)
- Healthcare resource utilization in a real-world setting(up to 112 weeks after initiation of benralizumab)
- change in treatment satisfaction in a real-world setting(up to 112 weeks after initiation of benralizumab)
- Change in patient-reported asthma related symptoms up to 112 weeks after initiation of benralizumab in a real-world setting(up to 112 weeks after initiation of benralizumab)