Patient-Reported Outcomes of Benralizumab in Real-World Use in Severe Eosinophilic Asthma Patients in Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting
研究概览
简要总结
An open-label, single-arm, non-interventional, prospective, multicenter study involving primary data collection within real-world settings for patients who receive benralizumab for treatment of severe uncontrolled eosinophilic asthma
详细描述
Benralizumab (Fasenra®) is a respiratory biologic agent targeting interleukin-5 (IL-5), an important member of the inflammatory cascade responsible for the pathogenesis of severe asthma. In 2019, Taiwan Food and Drug Administration (TFDA) approved benralizumab for the treatment of severe eosinophilic asthma (SEA). Since March 2020, benralizumab has been reimbursed by Taiwan National Health Insurance (NHI).
This prospective study (BEAT) aims to understand the use, effectiveness, and patient reported outcomes (PRO) of reimbursed benralizumab treatment in a real-world setting in Taiwan.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects eligible for enrolment in the study and treated with benralizumab according to Taiwan label and reimbursement criteria must meet ALL the following criteria:
- •Male or female patients ≥ 18 years of age (or ≥ 20 years of age for patients enrolled before January 1st, 2023, according to age of majority as defined by Taiwan regulations), with physician's confirmed diagnosis of severe uncontrolled asthma
- •Asthma requiring medium- or high-dose inhaled corticosteroid plus long-acting β-adrenoceptor agonist as maintenance treatment
- •Patients who have been prescribed but not yet initiated* treatment with reimbursed benralizumab (Fasenra®) according to the SmPC, prior to signed informed consent, and for whom the decision to prescribe this therapy is clearly separated from the physician's decision to include the patient in the current study. *Note: Treatment may be initiated (administration of first injection) at or after enrolment.
- •Benralizumab Taiwan reimbursement criteria:
- •≥ 2 acute exacerbations in the last 12 months, including at least 1 associated with emergency department (ED) visit or hospitalization; AND
- •At least 6 months of maintenance OCS use at ≥ 5 mg/day of prednisolone or equivalent dose; AND
- •Peripheral blood eosinophil ≥ 300 cells/μL in the last 12 months within the year before the initiation of benralizumab.
- •Provision of signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation
- •Patients must be able and willing to read, comprehend written instructions, and complete the paper questionnaires required by the protocol (ACQ-5, PGI-C, and PGI-S).
- •In case a patient does not own a smartphone or is not willing to perform the home spirometer, enrolment into the study is up to the physicians' discretion. We anticipate that 90% of patients will participate the home spirometer assessment.
排除标准
- •Subject must not meet ANY exclusion criteria:
- •Documented active lung diseases other than asthma and not within reimbursed label
- •Currently enrolled in an interventional clinical study in parallel, except:
- •Patients being in parallel documented in a national asthma registry
- •Patients having completed any other clinical trials including those with biologic treatment.
- •An acute or chronic condition that, in the investigator's opinion, would limit the patients' ability to complete questionnaires, participate in this study, or impact the interpretations of results.
- •Concurrent biologics for asthma are not allowed. Acceptable wash-out periods for other asthma biologics: ≥ 30 days from last dose of previous biologics.
- •Patients already started benralizumab treatment are not allowed. If the patients had received benralizumab treatment before, there should be an interval of ≥ 6 months from the last dose of prior benralizumab course to the newly initiated benralizumab treatment.
结局指标
主要结局
To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting
时间窗: at 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment
Percentage of patients with well-controlled asthma (ACQ-5 ≤ 0.75), partly controlled asthma (ACQ-5 between \> 0.75 and \< 1.5) and not well-controlled asthma (ACQ-5 ≥ 1.5) scored from 0 (totally controlled) to 6 (severely uncontrolled)
次要结局
- To assess change in overall asthma status and disease severity after initiation of benralizumab(Changes from baseline after 1, 2, 3, 4, 8, 24, and 56 weeks)
- To determine the change on lung function after treatment with benralizumab(after 24 and 56 weeks of treatment with benralizumab)
- To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting(in the past 12 months)
- To assess the rate and change of acute exacerbations after initiation of benralizumab in a real-world Taiwan setting(at Week 24 and 56)
- To assess the ability to reduce OCS dose after initiation of benralizumab in a real-world Taiwan setting(at Week 4, 8, 24, and 56)