NCT01035853已完成2 期
Sino-nasal Inhalation of Colistin Via the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Colonization of the Upper Airways With Pseudomonas Aeruginosa
University of Jena5 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2009年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 5
- 主要终点
- Decrease of Pseudomonas aeruginosa in Nasal lavage fluid
研究概览
简要总结
The purpose of this study is to determine whether the nasal inhalation of Colistin is effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subject has a confirmed diagnosis of cystic fibrosis
- •detection of P. aeruginosa in nasal lavage (culture) with chronic P.a. colonization of the lung (from day -28)
- •informed consent of the patients or parents
- •subject >= 6 years
- •subject is able to comply with the inhalation procedures and nasal lavage procedures scheduled in the protocol
- •women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol
排除标准
- •subject has a critical condition defined as: forced expiratory volume at one second < 30% and / or arterial oxygen saturation < 93% without O2-substitution; need of O2-substitution
- •subject had an ear, nose, and throat surgery within 3 months prior to study
- •subject shows signs of nasal bleeding
- •subject has an ear drum perforation
- •subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy against pseudomonas aeruginosa
- •subject is unlikely to comply with the procedures scheduled in the protocol
- •subject has a known allergic reaction to the medication
- •subject is pregnant or breastfeeding
- •subject participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study.
- •systemic (oral or intravenous) antibiotic treatment against P.a. 14 days prior to the inclusion and during the study
结局指标
主要结局
Decrease of Pseudomonas aeruginosa in Nasal lavage fluid
时间窗: 60 days
次要结局
未报告次要终点
研究者
PD Dr. Jochen G. Mainz
PD Dr.
University of Jena
研究点 (5)
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