NCT02182635已完成3 期
A Phase III Long-term Study of Ba253BINEB in Patients With COPD
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 主要终点
- Number of Patients with Adverse Events
研究概览
简要总结
The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria
- •Patients with FEV1.0/FVC (Forced vital capacity) of <= 70% in the screening test and whose symptoms are stable
- •Patients aged >= 40 years or older
- •Patients must be able to understand the patient information form
排除标准
- •Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
- •Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the study
- •Patients using oral corticosteroid medication at a dose in excess of the equivalent 5 mg/day of prednisolone
- •Patients with glaucoma
- •Patients who have prostatic hypertrophy
- •Patients with hypersensitivity to anticholinergic drugs
- •Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study
- •Women who are pregnant or who may become pregnant, or nursing women
- •Patients who are judged by the investigator as inappropriate as the subjects of the study
研究组 & 干预措施
Ba253BINEB
Experimental
干预措施: Ba253BINEB (Drug)
结局指标
主要结局
Number of Patients with Adverse Events
时间窗: Up to 28 weeks
Number of patients with significant changes from baseline in vital signs (blood pressure, heart rate)
时间窗: Baseline, up to week 28
Number of patients with abnormal changes from baseline in electrocardiogram (ECG)
时间窗: Baseline, up to week 28
Number of patients wiht abnormal changes from baseline in laboratory tests
时间窗: Baseline, up to week 28
次要结局
- Patient's impression(Week 28)
- Change from baseline in FEV1 (Forced expiratory volume in one second)(Baseline, up to week 28)
- Change from baseline in COPD symptom scoring (cough, sputum amount, shortness of breath, nocturnal sleep)(Baseline, up to week 28)
- Physician's global evaluation (overall improvement)(Up to week 28)
- Physician's global evaluation (final improvement)(Week 28)
研究者
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