NCT00774072已完成2 期
Nasal Inhalation of Tobramycin by the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization in the Upper Airways
University of Jena2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid
研究概览
简要总结
The purpose of this study is to determine whether the nasal inhalation of Gernebcin® 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 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 is older than 7 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: FEV1 < 30% and / or SaO2 < 93% without O2-substitution; need of O2-substitution
- •subject had an ENT 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 aerug.
- •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
- •if serum level of tobramycin is above 2 mg/l one hour after inhalation, subject has to withdraw the participation in the study.
- •progressed renal insufficiency
- •severe damage of the N. acusticus
- •dizziness (potential damage of. N. vestibularis)
研究组 & 干预措施
Tobramycin 80 mg
Active Comparator
applied once daily via Pari Sinus nebulizer
干预措施: Tobramycin (Gernebcin®) (Drug)
isotonic saline
Placebo Comparator
applied once daily via Pari Sinus nebulizer
干预措施: Tobramycin (Gernebcin®) (Drug)
结局指标
主要结局
Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid
时间窗: day -1, 1, 29, 30, 59, 60
次要结局
- Tolerability(day 1, 30 and 60)
- Measure of serum levels of tobramycin(day 1, 30 and 60)
研究者
PD Dr. Jochen G. Mainz
Head, CF Center
University of Jena
研究点 (2)
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