Utilisation of Benralizumab in the Clinical Practise in Severe Eosinophilic Asthma Patients in Switzerland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Change from baseline ACQ-5 score after 8 weeks after initiation of benralizumab
研究概览
简要总结
BEEPS describes the utility of patient reported outcomes (PRO) as simple, pragmatic, and sensitive tool to assess early treatment response of benralizumab to document the level of asthma control and change in medication after 1 to 16 weeks post-treatment initiation including use of OCS. The generated data on the time of asthma symptom relief after initiation of benralizumab will support patient management for a better disease control in severe asthma patients under benralizumab treatment. To assess long term outcomes the patients will have a last mandatory visit after 56 weeks, with no visits scheduled between week 16 and 56.
详细描述
The aim and objective of this single arm, prospective observational study is to describe patient reported outcomes (PRO) in severe eosinophilic asthma patients who are treated with benralizumab according to the label granted in Switzerland. The PRO measures consist of the weekly Asthma Control Questionnaire (ACQ-5) as well as Patient Global Impression of Change and Severity (PGI-C and PGI-S) collected at each visit (0, 1, 2, 4, 8, 16, 56 weeks). In addition the patient fills out twice daily the patient electronic asthma diary (eDiary) capturing daily symptoms and symptom free days together with a PEF (Peak Expiratory Flow) measurement. Persistance with eDiary and PEF will be assessed after 56 weeks. The percentage of patients successfully reducing their OCS dose will be evaluated after 16 weeks of treatment with benralizumab and if OCS reduction is persistent until week 56. Furthermore, the proportion of patients with an ACQ-5 score improvement of ≥ 0.5 after 8 weeks of treatment with benralizumab will be determined. In addition, the study will assess changes in FEV1 and FVC after 8, 16 and 56 weeks of treatment with benralizumab and describe retrospectively asthma disease history, past treatment status and current medication at baseline.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Subject eligible for enrolment in the study and treatment for benralizumab according to the specific Swiss label must meet all the following criteria:
- •Male or female patients older than 18 years with physician's confirmed diagnosis of severe, uncontrolled asthma according to ATS/ERS guidelines.
- •Asthma requiring high-dose ICS plus LABA as maintenance treatment.
- •Minimum of 2 exacerbations in the last 12 months.
- •Documented peripheral blood eosinophil count ≥ 300 cells/μL blood.
- •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 (ACQ-5, PGI-C and PGI-S).
排除标准
- •Subjects meeting any of the following criteria will not be eligible to participate in the study:
- •Documented lung diseases other than asthma, e.g. COPD, and not within reimbursed label, e.g pregnancy or lactation.
- •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 trial including those with biologic treatment.
- •An acute or chronic condition that, in the investigator's opinion, would limit the patients' ability to complete questionnaires or participate in this study or impact the interpretations of results.
结局指标
主要结局
Change from baseline ACQ-5 score after 8 weeks after initiation of benralizumab
时间窗: 8 weeks
The ACQ-5 (Asthma Control Questionnaire - 5 questions) consists of 5 questions about the asthma symptoms in the last 7 days. Each question has a scale from 0 (no symptoms) to 6 (most severe). The reported mean score of all questions describes the level of asthma control (0-6) whereby a mean score \>1,5 is considered as uncontrolled asthma.
次要结局
- Proportion of patients with a total score improvement of ≥ 0.5 in ACQ-5 under treatment with benralizumab.(1,2,4,8,16,56 weeks)
- Patient demographics(Baseline)
- Change from baseline in ACQ 5 score up to 16 weeks after initiation of treatment with benralizumab.(1, 2, 4, 16, 56 weeks)
- Past treatment status(Baseline)
- Percentage of patients on OCS who were able to reduce their OCS after 16 weeks.(16, 56 weeks)
- Change from baseline in PGI-C in asthma.(1, 2, 4, 8, 16, 56 weeks)
- Change from baseline in PGI-S in asthma(1, 2, 4, 8, 16, 56 weeks)
- Asthma disease history(Baseline)