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临床试验/NCT04108962
NCT04108962撤回4 期

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

Baylor Research Institute1 个研究点 分布在 1 个国家开始时间: 2019年12月23日最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Treatment

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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