Patient Outcomes Real World Evidence Registry (POWER): Patient Reported Outcomes in a Cohort of Canadian Adults With Severe Eosinophilic Asthma on Benralizumab.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Change of at least 0.5 units in ACQ-6 after initiation of benralizumab
研究概览
简要总结
This study will generate patient reported outcomes (PROs) associated with the use of benralizumab as treatment for severe eosinophilic asthma.
详细描述
Benralizumab was launched in 2018 following regulatory approval in Canada and is now widely available for Canadian patients with severe eosinophilic asthma.
This study is an observational cohort study of patient reported outcomes (PROs) within real-world settings for participants who are prescribed benralizumab for treatment of uncontrolled severe eosinophilic asthma. Patients will be recruited in select clinics across Canada.
Survey data for each participant in the study will be obtained at the following time-points:
- Baseline (Week 0)
- Short-term follow up: 1-, 2-, 4-, and 8-weeks after baseline
- Long-term follow-up: 24- and 56-weeks after baseline
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change of at least 0.5 units in ACQ-6 after initiation of benralizumab
时间窗: Up to week 56 (from 1st dose of benralizumab)
ACQ-6 is able to identify the adequacy of asthma control in individual patients. Data will be presented as the proportion of patients achieving a change of at least 0.5 units following initiation of therapy.
次要结局
- Number of exacerbations(Up to week 56 (from first dose of benralizumab))
- EuroQol 5 Dimension, 5 Level (EQ-5D-5L)(Up to week 56 (from first dose of benralizumab))
- Asthma Quality of Life Questionnaire, Symptoms (AQLQ(S)+12)(Up to week 56 (from first dose of benralizumab))
- Change in concomitant medications(Up to week 56 (from first dose of benralizumab))
- Number of participants with Serious Adverse Events and hospitalizations(Up to week 56 (from first dose of benralizumab))
- Health care resource utilization(Up to week 56 (from first dose of benralizumab))
- Patient Global Impression of Severity (PGI-S)(Up to week 56 (from first dose of benralizumab))
- Patient Global Impression of Change (PGIC)(Up to week 56 (from first dose of benralizumab))
- Treatment Satisfaction Questionnaire for Medication (TSQM-9)(Up to week 56 (from first dose of benralizumab))