NCT02172352已完成2 期
Dose Ranging Study of Ba 679 BR Inhalation Powder Following Single Inhalation in COPD Patients - Double-blind, Placebo-controlled, 4 Treatment, 4 Period Crossover Study-
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- FEV1.0 max (maximum forced expiratory volume in one second)
研究概览
简要总结
To investigate the dose response following single inhalation of Ba 679 BR inhalation powder in COPD patients using pulmonary functions as indicators, and to compare data obtained with overseas study findings
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •In a pulmonary function test of Screening Test II, FEV1.0 was less than 70% of predict normal and FEV1.0 was less than 70% of FVC.
- •In the reversibility test of Screening Test II, FEV1.0 was improved by 10% or more at 1 hour after inhalation of 2 puffs of an anticholinergic agent (Tersigan ® Aerozol)
- •History of smoking (< no. of cigarettes a day x no. of years of smoking > = 200 or more)
- •40 years of age or older
- •Regardless of sex and the length of disease period
排除标准
- •A history of bronchial asthma
- •A history of atopic disease, such as allergic rhinitis
- •Blood eosinophil of 440/µl or more
- •Continuous use of steroid drugs (oral administration, inhalation or injection) at a dose equivalent to over 5 mg daily of prednisolone
- •A history of respiratory infection, including virus infection within 1 month before study initiation
- •Tuberculosis, lung cancer or a history of pneumonectomy
- •Under treatment of benign prostatic hypertrophy
- •Hypersensitivity to anticholinergic agents or sympathomimetics
- •Difficulty in expectoration of sputum
- •Serious heart disease, renal disease, hepatic disease, endocrine disease or metabolic disease
- •Use of any β blockers
- •A history of myocardial infarction within the past 1 year
- •A history of heart failure, cor pulmonale or arrhythmia requiring medication within the past 3 years
- •A history of drug abuse or alcoholism
- •Treatment of psychotic disease
- •Pregnancy, possible pregnancy or lactation
- •A history of participation in any other clinical studies within the past 6 months
- •Judgment by the investigator that the patient is ineligible for inclusion in the present study
研究组 & 干预措施
Ba 679 BR low dose
Experimental
干预措施: Ba 679 BR low dose (Drug)
Placebo inhalation powder
Placebo Comparator
干预措施: Placebo inhalation powder (Drug)
Ba 679 BR middle dose
Experimental
干预措施: Ba 679 BR middle dose (Drug)
Ba 679 BR high dose
Experimental
干预措施: Ba 679 BR high dose (Drug)
结局指标
主要结局
FEV1.0 max (maximum forced expiratory volume in one second)
时间窗: before and up to 24 hours after each study drug administration
次要结局
- FEV1.0 time to response(before and up to 24 hours after each study drug administration)
- FEV1.0 AUC 0-24 (forced expiratory volume in one second as area under the curve 0 to 24 hours after administration)(before and up to 24 hours after each study drug administration)
- FEV1.0 Tmax (time to FEV1.0 max)(before and up to 24 hours after each study drug administration)
- FEV1.0 at measuring time points up to 24 hours after administration of study drug(before and up to 24 hours after each study drug administration)
- FVC AUC 0-24 (forced vital capacity as area under the curve 0 to 24 hours after administration)(before and up to 24 hours after each study drug administration)
- FVC max(before and up to 24 hours after each study drug administration)
- FVC at measuring time points up to 24 hours after administration of study drug(before and up to 24 hours after each study drug administration)
- Occurrence of adverse events(up to 29 days)
- Changes in blood pressure(before and up to 24 hours after each study drug administration)
- Changes in pulse rate(before and up to 24 hours after each study drug administration)
- Changes in transdermal O2 saturation(before and up to 24 hours after each study drug administration)
- Abnormal findings in electrocardiogram (ECG)(before and 1.5 and 24 hours after each administration of study drug)
- Abnormal changes in laboratory measurements(at 24 hours after last study drug administration)
- Urinary excretion rate(before (from 4 hours pre-dosing until immediately before dosing) and 0-2, 2-4, 4-8, 8-12 and 12-24 hours after drug administration)
- MMEF AUC 0-24 (maximal midexpiratory flow as area under the curve 0 to 24 hours after administration)(before and up to 24 hours after each study drug administration)
- MMEF max(before and up to 24 hours after each study drug administration)
- MMEF at measuring time points up to 24 hours after administration of study drug(before and up to 24 hours after each study drug administration)
研究者
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