NCT01052298已完成1 期
Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Tolerability, the Pulmonary Deposition and Pharmacokinetics of Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (GOLD I - II), Following Inhalation of Ciprofloxacin PulmoSphere Inhalation Powder.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 25
- 主要终点
- Vital signs: evaluated by heart rate, blood pressure, clinical laboratory
研究概览
简要总结
Objectives of the study are to investigate the safety, tolerability and levels of ciprofloxacin in the lung after single and multiple inhalative administration to patients with mild to moderate COPD (stage I-II according to GOLD Criteria).
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with COPD (Stage I or II according to the GOLD Classification), 35 years of age or older
- •Airway obstruction with a post-bronchodilator Forced Expiratory Volume (FEV1) > or equal 50% of predicted normal and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) < 70%.
- •Current or ex-smokers with a smoking history of more than 10 pack-years
- •Body mass index (BMI) between 18 and 33 kg/m2
- •Written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures
排除标准
- •Significant disease other than COPD as bronchial asthma, cystic fibrosis or clinically evident bronchiectasis
- •Total blood eosinophil count >/=600/mm
- •Thoracotomy with pulmonary resection
- •Regular use of daytime oxygen therapy
- •Completion of a pulmonary rehabilitation program in the six weeks prior to the pre-study examination or current participation in a rehabilitation program
- •Hypersensitivity to the investigational drug or to other quinolones and/or to inactive constituents of the inhalation powder
- •Hypersensitivity of the bronchial system to inhalation of nebulized drugs or saline solution
- •Acute pulmonary exacerbation
- •Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
- •Concomitant inhalative therapy with antibiotics and/or concomitant systemic therapy with fluoroquinolones
- •Oral beta-adrenergics, beta blockers
- •Long acting anti-cholinergics within 2 weeks prior to pre-study examination
- •Inhaled or oral steroids
- •Methylxanthines: 24-hour washout of short-acting theophylline and 48-hour washout of long-acting theophylline prior to pre-study examination
- •Antihistamines, antileukotrienes prescribed for asthma
- •oral cromolyn sodium or oral nedocromil sodium
研究组 & 干预措施
Arm 1
Experimental
干预措施: Ciprofloxacin (Cipro inhale, BAYQ3939) (Drug)
Arm 2
Experimental
干预措施: Ciprofloxacin (Cipro inhale, BAYQ3939) (Drug)
Arm 3
Experimental
干预措施: Ciprofloxacin (Cipro inhale, BAYQ3939) (Drug)
Arm 4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Vital signs: evaluated by heart rate, blood pressure, clinical laboratory
时间窗: Within 28 days after first treatment
Electrocardiogram: evaluated by shape and time intervals
时间窗: Within 28 days after first treatment
Pulmonary function test evaluated by FEV1
时间窗: Within 28 days after first treatment
Pulse oximetry by peripheral oxygen concentration
时间窗: Within 12 days after first treatment
次要结局
- Determination of ciprofloxacin concentration in blood(Within 14 days after first treatment)
- Determination of ciprofloxacin concentration in urine(Within 14 days after first treatment)
- Determination of ciprofloxacin concentration in sputum(Within 14 days after first treatment)
- Determination of ciprofloxacin concentration in oral rinsing fluid(Within 7 days after first treatment)
研究者
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