NCT00910351已完成1 期
A Study to Evaluate the Safety and Pharmacokinetics of Ciprofloxacin in Adults and Children Aged 6 - 12 Years With Cystic Fibrosis Following Inhalation of Ciprofloxacin Dry 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
- 19
- 主要终点
- To investigate the safety and tolerability of inhaled ciprofloxacin given as single inhalation dose to pediatric CF patients, aged 6 - 12 years
研究概览
简要总结
Ciprofloxacin PulmoSphere Inhalation Powder appears to be an effective and adequate antibiotic treatment for cystic fibrosis patients with P. aeruginosa colonisation. This planned study is the first study on the use of this new Ciprofloxacin PulmoSphere Inhalation Powder in the pediatric population of 6 to 12 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with cystic fibrosis confirmed by genetic testing and / or by sweat test
- •Colonization with P. aeruginosa confirmed in sputum in the past 12 months
- •Cohort 1: greater than or equal to 18 years of age.
- •Cohort 2: 6 - 12 years of age (inclusive)
- •Normal Body Mass Index: BMI between 14.5 and 30 kg/m2, but in no case lower than the 30th percentile for age. Because CF patients are typically smaller than non-CF-patients, the normal body mass index will be based on standard CF foundation normal values for weight and sex.
- •Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period.
- •Patients and legal representatives must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures
排除标准
- •Patients with FEV1 < 35% of predicted. FEV1 (forced expiratory volume) is a measure of lung function. This exclusion will prohibit enrollment of patients with severely impaired lung function.
- •Patients with Burkholderia cepacia colonization of their respiratory tract
- •Patients with acute bronchopulmonary aspergillosis (ABPA)
- •Patients on a lung transplant list
- •Patients with acute pulmonary exacerbations
- •Patients with severe liver cirrhosis
- •Massive hemoptysis in the preceding 4 weeks
- •A history of relevant diseases of vital organs, of the central nervous system, or other organs not related to the underlying disease
- •Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
- •Patients with hypersensitivity to the investigational drug or to other quinolones and/ or to inactive constituents
- •Patients with known intolerance to hypertonic saline or bronchodilators
- •Concomitant inhalation therapy with antibiotics and / or concomitant systemic therapy with fluoroquinolones
- •Women who are pregnant
研究组 & 干预措施
Arm 1
Experimental
干预措施: Ciprofloxacin (Cipro, BAYQ3939) (Drug)
结局指标
主要结局
To investigate the safety and tolerability of inhaled ciprofloxacin given as single inhalation dose to pediatric CF patients, aged 6 - 12 years
时间窗: Two weeks post screening
次要结局
- To investigate the pharmacokinetics of ciprofloxacin in plasma and sputum after inhalation administration(Day 1)
研究者
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