Phase IV, Single-Center, Open-Label Study Evaluating the Effects of an Anti-IL5 Receptor Alpha (Benralizumab) Monoclonal Antibody in the Treatment of Severe Asthma in Patients With Allergic Bronchopulmonary Aspergillosis
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of steroid requiring exacerbations
研究概览
简要总结
Phase IV, open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis
详细描述
Subjects who have been identified to have severe asthma with ABPA will be consented and enrolled in the study to receive benralizumab injections administered every 4 weeks for the first 3 injections with an additional injection eight weeks to follow for a total of 16 weeks active treatment with a follow-up/termination visit eight weeks from the last injection. The termination visit will occur week 24 for subjects who complete the study treatment. Subjects who receive the first dose of benralizumab but withdraw from the study or terminate study treatment for any reason should complete all the procedures outlined for the termination visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 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
研究组 & 干预措施
Treatment
Benralizumab treatment will be given by injections administered every 4 weeks for the first 3 injections with an additional injection eight weeks to follow for a total of 16 weeks active treatment
干预措施: Fasenra, 30 Mg/mL Subcutaneous Solution (Drug)
结局指标
主要结局
Number of steroid requiring exacerbations
时间窗: 26 Weeks
Number of asthma exacerbations requiring the initiation of (or temporary increase in) systemic corticosteroids in severe asthma complicated by ABPA
次要结局
- Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire(26 Weeks)
- Lung Function (FEV1)(26 Weeks)
- Asthma Control as assessed by Asthma Control Questionnaire 6(26 Weeks)