NCT01947946终止3 期
A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to Medium-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 13
- 试验地点
- 48
- 主要终点
- Asthma Exacerbations Over 48 Weeks Treatment
研究概览
简要总结
The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on medium doses of ICS-LABA.
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 75 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 and male aged from 18 to 75 years, inclusively
- •History of physician-diagnosed asthma requiring treatment with medium dose ICS (>250ug fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1
- •Documented treatment with medium-dose ICS (>250ug and ≤500ug fluticasone dry powder formulation equivalents total daily dose) and LABA for at least 3 month prior to Visit 1
排除标准
- •Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)
- •Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: - Affect the safety of the patient throughout the study - Influence the findings of the studies or their interpretations - Impede the patient's ability to complete the entire duration of study
- •Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
- •Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study
研究组 & 干预措施
Placebo
Placebo Comparator
A (Dummy) injection
干预措施: Placebo (Biological)
Benra 30 mg - Placebo q.8 Weeks
Experimental
Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
干预措施: Benralizumab (Biological)
Benra 30 mg q.4 Weeks
Experimental
Fixed 30 mg dose of benralizumab (every 4 weeks)
干预措施: Benralizumab (Biological)
结局指标
主要结局
Asthma Exacerbations Over 48 Weeks Treatment
时间窗: 48 weeks treatment
The number of asthma exacerbations over 48 weeks treatment will be counted
次要结局
未报告次要终点
研究者
研究点 (48)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled AsthmaAsthmaNCT01928771AstraZeneca2,681
已完成
3 期
A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma.AsthmaNCT03170271AstraZeneca660
已完成
3 期
Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 AgonistAsthmaNCT01914757AstraZeneca2,508
终止
2 期
Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With AsthmaAsthmaNCT02336425Novartis Pharmaceuticals10
已完成
4 期
GSK BHR Study (Sont)AsthmaNCT00920543GlaxoSmithKline464