NCT02182583已完成3 期
A Phase III Study of Ba253BINEB in Patients With COPD - Double-blind, Randomised, Double Dummy, Multiple Dose Study in Comparison With MDI
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
- 163
- 主要终点
- Change in COPD daily symptom scores
研究概览
简要总结
The objective of this study is to investigate the efficacy and safety of Ba253BINEB during the continuous 4 weeks administration to the patients with COPD using Ba253MDI (Tersigan® aerosol) as the comparator drug.
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
- Double
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 whose symptoms are stable and have at least 4 symptomatic days a week
- •Patients with FEV1.0/FVC of <= 70% in the screening test
- •Patients aged >= 40 years or older
- •Patients must be able to inhale the study drug via BINEB and MDI
- •Patients must be able to understand the patient information form
排除标准
- •Those who correspond to the following shall be excluded from the subjects of study.
- •Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
- •Patients who are constantly administered oral steroid
- •Patients with glaucoma
- •Patients who have prostatic hypertrophy
- •Patients with hypersensitivity to anticholinergic drugs or Beta2 agonists.
- •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)
Ba253MDI
Active Comparator
干预措施: Ba253MDI (Drug)
结局指标
主要结局
Change in COPD daily symptom scores
时间窗: Baseline and up to 4 weeks after first drug administration
次要结局
- Number of Patients with Adverse Events(Up to 4 weeks)
- Number of patients with abnormal changes in laboratory values(Baseline, week 4)
- Physician's global evaluation(4 weeks after first drug administration)
- Change from baseline in times and volume of sputum(Baseline, up to 4 weeks after first drug administration)
- Change from baseline in FVC (Forced vital capacity)(Baseline, week 4)
- Change from baseline in times of cough(Baseline, up to 4 weeks after first drug administration)
- Number of patients with significant changes in vital sings (blood pressure, pulse rate)(Baseline, week 4)
- Change from baseline in transition of nocturnal sleep(Baseline, up to 4 weeks after first drug administration)
- Change from baseline in peak expiratory flow rate (PEFR)(Baseline, up to 4 weeks after first drug administration)
- Number of patients with abnormal changes in electrocardiogram (ECG)(Baseline, week 4)
- Patient's impression(4 weeks after first drug administration)
- Change from baseline in FEV1 (Forced expiratory volume in one second)(Baseline, week 4)
研究者
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