Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pulmonary Deposition, Pharmacokinetics and Pharmacodynamics of Ciprofloxacin in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD; GOLD II-III), Following Multiple Inhalation of Ciprofloxacin PulmoSphere Inhalation Powder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 16
- 主要终点
- Adverse event collection
研究概览
简要总结
The study will be conducted in a single-center, randomized, single-blinded, placebo-controlled, dose escalation design with two dose groups.Multiple-dose inhalation of Ciprofloxacin inhale 50 and 75 mg or placebo will be administered to 16 Japanese patients with COPD in totalPatients with moderate to severe COPD, stage II or III according to GOLD criteria, will participate in the study.The study will consist of 2 steps as indicated below; starting at Step 1 (50 mg) and escalating doses up to Step 2 (75 mg), after the tolerability of the dose in the previous step is confirmed. In each step, the study will be conducted as multiple dose study with b.i.d. regimen for 10 days (between day 2 and 11) in a randomized, single-blind, placebo-controlled design. In addition, before and after the multiple dose administration, single administration will be conducted in each subject (day 0 and 12).
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with COPD, 40 to 80 years of age
- •All patients must have a diagnosis of COPD and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post-bronchodilator 30% </= Forced Expiratory Volume (FEV1) </= 65% of predicted normal. And a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) <70%.
排除标准
- •Patients with a significant respiratory disease other than COPD. A significant disease is defined as a disease which, in the opinion of the investigator
- •Patients with a medical disorder, condition or history of such that would impair the patients ability to participate or complete this study in the opinion of the investigator, patients who have mental disorder which is inappropriate to communal living in a participation in a clinical study, who have no ability to give informed consent, or who have physical disability
- •Patients with a history of CF
- •Patients with clinically evident bronchiectasis
- •Patients with a history of asthma
- •Patients who have undergone thoracotomy with pulmonary resection
- •Patients with relevant conspicuous findings in medical history and pre-study examination not related to the underlying disease
研究组 & 干预措施
Arm 1
干预措施: Ciprofloxacin (Cipro InhaIe, BAYQ3939) (Drug)
Arm 2
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse event collection
时间窗: Up to 3 weeks
次要结局
- Microbiological examination(14 days)
- Ciprofloxacin concentration in sputum(14 days)
- Ciprofloxacin concentration in plasma(14 days)