A Double-Blind, Randomized, Parallel Group, Placebo-Controlled Multi-Centre Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 46
- 试验地点
- 7
- 主要终点
- Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge
研究概览
简要总结
This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks on allergen-induced inflammation in subjects with mild atopic asthma challenged with an inhaled allergen.
详细描述
This randomized, double-blind, parallel group, placebo-controlled study will evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks for 3 doses on allergen-induced inflammation in subjects with mild atopic asthma challenged with an inhaled allergen.
Approximately 38 non-smoking men and women (18 - 65 years of age) corticosteroid-free (oral and inhaled) mild, atopic asthmatics who have demonstrated a dual (early and late) asthmatic response to inhaled allergen challenge at screening will be recruited to complete the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Female or male aged 18 to 65 years, inclusively, at the time of enrolment.
- •General good health
- •Mild, stable, allergic asthma and asthma therapy limited to inhaled, short-acting beta 2 agonists (not more than twice weekly)
- •Positive skin-prick test to at least one common aeroallergen
排除标准
- •Current lung disease other than mild allergic asthma
- •Any history or symptoms of disease, including, but not limited to, cardiovascular, neurologic, autoimmune or haematologic
- •Any clinically significant abnormal findings in laboratory test results in complete blood count, coagulation, chemistry panel and urinalysis at enrolment and during screening period
- •History of anaphylaxis to any biologic therapy or vaccine
结局指标
主要结局
Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge
时间窗: From prechallenge to 7 hours post allergen challenge during week 9
To evaluate the effect of benralizumab on allergen-induced increases in eosinophils in induced sputum
Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge
时间窗: From prechallenge to 3 to 7 hours post allergen challenge during week 9
To evaluate the effect of benralizumab on the allergen-induced late (3-7 hours post challenge) asthmatic response (LAR)
次要结局
未报告次要终点