NCT01914757已完成3 期
A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,508
- 试验地点
- 217
- 主要终点
- Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
研究概览
简要总结
The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.
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
- •Provision of informed consent prior to any study specific procedures
- •Female and male aged 12 to 75 years, inclusively, at the time of Visit 1
- •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
- •Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.
- •Exclusion criteria:
- •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
排除标准
- 未提供
结局指标
主要结局
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
时间窗: Immediately following the first administration of study drug through Study Week 56.
The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
次要结局
- Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL(Immediately following the first administration of study drug through Study Week 56.)
- Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL(Immediately following the first administration of study drug through Study Week 56.)
- Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL(Immediately following the first administration of study drug through Study Week 56.)
- Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL(Immediately following the first administration of study drug through Study Week 56.)
- Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL(Immediately following the first administration of study drug through Study Week 56.)
- Change in Asthma Rescue Medication Use(Immediately following the first administration of study drug through Study Week 56.)
- Home Lung Function Assessments Based on PEF(Immediately following the first administration of study drug through Study Week 56.)
- Proportion of Nights With Awakening Due to Asthma(Immediately following the first administration of study drug through Study Week 56.)
- Time to First Asthma Exacerbation(Immediately following the first administration of study drug through Study Week 56)
- Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations(Immediately following the first administration of study drug through Study Week 56.)
- Pharmacokinetics of Benralizumab(Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60)
- Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL(Immediately following the first administration of study drug through Study Week 56.)
- Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL(Immediately following the first administration of study drug through Study Week 56.)
- Number of Patients With >=1 Asthma Exacerbation(Immediately following the first administration of study drug through Study Week 56)
- Immunogenicity of Benralizumab(Pre-treatment until end of follow-up)
- Extent of Exposure(Immediately following the first administration of study drug through Study Week 56)
- Mean Change From Baseline to Week 56 in AQLQ(S)+12(Immediately following the first administration of study drug through Study Week 56)
- Change From Baseline to Week 56 in EQ-5D-5L VAS(Immediately following the first administration of study drug through Study Week 56)
- Mean Work Productivity Loss Due to Asthma(Immediately following the first administration of study drug through Study Week 56)
- Mean Productivity Loss Due to Asthma in Classroom(Immediately following the first administration of study drug through Study Week 56)
- Number of Participants That Utilized Health Care Resources(Immediately following the first administration of study drug through Study Week 56)
- Patient and Clinician Assessment of Response to Treatment(Immediately following the first administration of study drug through Study Week 56)
研究者
研究点 (217)
Loading locations...
相似试验
已完成
3 期
A Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic InflammationAsthmaNCT02869438AstraZeneca233
终止
3 期
A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid.Bullous PemphigoidNCT04612790AstraZeneca67
终止
3 期
Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled AsthmaAsthmaNCT01947946AstraZeneca13
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