NCT01928771已完成3 期
A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to High-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
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,681
- 试验地点
- 280
- 主要终点
- Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL
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 high 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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent[s]/guardian[s]) and according to international guidelines and/or applicable European Union guidelines.
- •Female and Male aged 12 to 75 years inclusively, at the time of visit
- •For those patients, who are 17 on the day of Visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial.
- •History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1
- •Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers.
- •For subjects 18 years of age and older, the ICS dose must be >500 mcg/day fluticasone propionate dry powder formulation or equivalent daily.
- •For subjects ages 12-17, the ICS dose must be ≥500 mcg /day fluticasone propionate dry powder formulation or equivalent daily.
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
Placebo administered subcutaneously
干预措施: Placebo (Biological)
Benralizumab 30 mg q.8 weeks
Experimental
Benralizumab administered subcutaneously every 8 weeks
干预措施: Benralizumab (Biological)
Benralizumab 30 mg q.4 weeks
Experimental
Benralizumab administered subcutaneously every 4 weeks
干预措施: Benralizumab (Biological)
结局指标
主要结局
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL
时间窗: Immediately following the first administration of study drug through Study Week 48.
The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF
次要结局
- Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL(Immediately following the first administration of study drug through Study Week 48.)
- Home Lung Function Assessment Based on Evening PEF(Immediately following the first administration of study drug through Study Week 48.)
- Time to First Asthma Exacerbation(Immediately following the first administration of study drug through Study Week 48.)
- Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL(Immediately following the first administration of study drug through Study Week 48.)
- Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL(Immediately following the first administration of study drug through Study Week 48.)
- Proportion of Night Awakening Due to Asthma(Immediately following the first administration of study drug through Study Week 48.)
- Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL(Immediately following the first administration of study drug through Study Week 48.)
- Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL(Immediately following the first administration of study drug through Study Week 48.)
- Immunogenicity of Benralizumab(Pre-treatment until end of follow-up)
- Number of Patients With >=1 Asthma Exacerbations(Immediately following the first administration of study drug through Study Week 48.)
- Change in Asthma Rescue Medication(Immediately following the first administration of study drug through Study Week 48.)
- Home Lung Function Assessment Based on Morning PEF(Immediately following the first administration of study drug through Study Week 48.)
- Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL(Immediately following the first administration of study drug through Study Week 48.)
- Number of Participants That Utilized Health Care Resources(Immediately following the first administration of study drug through Study Week 48.)
- Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations(Immediately following the first administration of study drug through Study Week 48.)
- Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL(Immediately following the first administration of study drug through Study Week 48.)
- Mean Change From Baseline to Week 48 in AQLQ(S)+12(Immediately following the first administration of study drug through Study Week 48.)
- Pharmacokinetics of Benralizumab(Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56)
- Mean Change From Baseline to Week 48 in EQ-5D-5L VAS(Immediately following the first administration of study drug through Study Week 48.)
- Mean Work Productivity Loss Due to Asthma(Immediately following the first administration of study drug through Study Week 48.)
- Patient and Clinician's Responder Assessment to Treatment(Immediately following the first administration of study drug through Study Week 48)
- Extend of Exposure(Immediately following the first administration of study drug through Study Week 48.)
- Mean Productivity Loss Due to Asthma in Classroom(Immediately following the first administration of study drug through Study Week 48.)
研究者
研究点 (280)
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