NCT00961038
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 Moderate to Severe Chronic Obstructive Pulmonary Disease (GOLD II - III), Following Inhalation of Ciprofloxacin PulmoSphere® Inhalation Powder
概览
- 阶段
- 1 期
- 干预措施
- Ciprofloxacin (PulmoSphere, BAYQ3939)
- 疾病 / 适应症
- Pulmonary Disease, Chronic Obstructive
- 发起方
- Bayer
- 入组人数
- 19
- 主要终点
- Electrocardiogram (ECG)
- 状态
- 已完成
- 最后更新
- 12年前
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 moderate to severe COPD (stage II-III according to GOLD Criteria)
研究者
入排标准
入选标准
- •Adult patients with COPD, 40 to 75 years of age
- •Diagnosis of COPD
- •Airway obstruction with a post-bronchodilator Forced Expiratory Volume (FEV1) of \>/=30% and \</=65% of predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of \</=70%
- •Current or ex-smokers with a smoking history of more than 10 pack-years
- •Patients must be able to produce acceptable induced sputum samples (as defined in the Study Procedure Manual)
- •Normal body weight: Body Mass Index (BMI) between 19 and 35 kg/m2
排除标准
- •Significant respiratory disease other than COPD as bronchial asthma, Cystic fibrosis or clinically evident bronchiectasis
- •More than one COPD exacerbation within 12 months and within 8 weeks prior to screening
- •total blood eosinophil count \>/=600/mm3
- •Thoracotomy with pulmonary resection
- •Regularly use of daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits
- •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
- •Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
- •Concomitant use of medication which could interfere with the investigational drug. Before study drug administration a wash out period of more than 5 half lives has to be considered
- •Concomitant inhalative therapy with antibiotics and/or concomitant systemic therapy with
研究组 & 干预措施
Arm 1
干预措施: Ciprofloxacin (PulmoSphere, BAYQ3939)
Arm 2
干预措施: Ciprofloxacin (PulmoSphere, BAYQ3939)
Arm 3
干预措施: Placebo
结局指标
主要结局
Electrocardiogram (ECG)
时间窗: Within 28 days after first treatment
Vital signs
时间窗: Within 28 days after first treatment
Pulse-oximetry
时间窗: Within 12 days after first treatment
Pulmonary function test
时间窗: Within 28 days after first treatment
次要结局
- Ciprofloxacin concentrations in blood(Within 14 days after first treatment)
- Ciprofloxacin concentrations in urine(Within 14 days after first treatment)
- Ciprofloxacin concentrations in sputum(Within 14 days after first treatment)
- Ciprofloxacin concentrations in mouth fluid(Within 7 days after first treatment)
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