NCT06862206招募中不适用
A Multicentre, Single Arm, Non-interventional, Prospective Study to Assess Demographic Characteristics and Patient Reported Outcomes in Patients With Severe Eosinophilic Asthma Treated With Benralizumab in China
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 1,000
- 试验地点
- 37
- 主要终点
- asthma control questionnaire
研究概览
简要总结
The objective of this study is to collect empirical data that elucidates the clinical profile and therapeutic efficacy of benralizumab among the patients aged 12 years and above, with severe eosinophilic asthma. The study will focus on the early treatment response, treatment outcomes and the change in asthma control of benralizumab therapy in a real-world setting in China. This study will also describe the physician-reported reasons for discontinuation and switching of benralizumab therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible to be included in the study only if all of the following criteria apply:
- •Patients must to be 12 years old (inclusive) at the time of signing the informed consent.
- •Patients with severe eosinophilic asthma prescribed with benralizumab at the discretion of the clinician.
- •Blood EOS≥150/ul in the 3 months prior to or EOS≥300/ul in the 1 year prior to the time of signing the informed consent.
- •Participating patients and/or their legally authorized representative must provide signed and dated written informed consent form prior to any study specific procedures.
排除标准
- •Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- •Patients currently participating in any other clinical trial.
- •Known history of allergy or reaction to any component of the study treatment formulation.
- •Malignancy of any kind.
- •Patients with prior or ongoing treatment with benralizumab.
研究组 & 干预措施
benralizumab group
non-interventional
干预措施: benralizumab (Other)
结局指标
主要结局
asthma control questionnaire
时间窗: Week 8
To describe the change in asthma control questionnaire at early time point after initiation of benralizumab
次要结局
- asthma control questionnaire(week 1, 2, 4, 8, 16, 24, 40 and 56.)
- changes in lung function(week 8, 16 and 56)
研究者
研究点 (37)
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