jRCTs031240259招募中不适用
BENralizumab dosing interval Extension to 12 weeks in severe asthma patients; a multicenter phase II study to evaluate the safety and efFIcacy (BENEFIT trial)
未提供0 个研究点目标入组 30 人开始时间: 2024年11月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 主要终点
- Annual asthma exacerbation rate
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Diagnosis of bronchial asthma and continuous treatment with benralizumab for at least 1 year prior to study initiation.
- •(2) No more than 1 asthma exacerbation in the past year.
- •(3) No asthma exacerbations within the past 3 months.
- •(4) No increase in controller medication dosage due to symptom worsening in the past year (dose reductions or discontinuations of controllers are permitted).
- •(5) Age 18 years or older.
- •(6) Provision of written informed consent to participate in this study.
排除标准
- •(1) Current or prior use of other biologic agents for asthma within the past 1 year.
- •(2) History of severe asthma exacerbation requiring mechanical ventilation.
- •(3) Pregnant or lactating women, those with a possibility of being pregnant, or those who desire to become pregnant during the treatment period.
- •(4) Patients with a potential for parasitic infection.
- •(5) Any other patients deemed ineligible for the study based on the investigator's clinical judgment.
结局指标
主要结局
Annual asthma exacerbation rate
时间窗: Annual
Total number of exacerbations × 365.25 / total treatment period follow-up duration in days
次要结局
- Asthma Control Questionnaire (ACQ) score
研究者
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