EUCTR2008-000164-17-DE进行中（未招募）不适用
asale Inhalation von Tobramycin mit dem Pari Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of tobramycin by the Pari Sinus nebulizer in patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - tobra nasal CF pilot
niversity of Jena0 个研究点目标入组 14 人开始时间: 2008年5月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Subject has a confirmed diagnosis of cystic fibrosis based on:
- •3 positive sweat chloride tests and/or genetic characterisation
- •2.detection of P. aeruginosa in nasal lavage (culture) with chronic P.
- •aeruginosa colonization of the lung (from day – 28)
- •3.informed consent of the patients or parents
- •4.Subject is older than 7 years
- •5.Subject is able to comply with the inhalation procedures and nasal
- •lavage procedures scheduled in the protocol.
- •6.Women of childbearing potential are only included into the study, if they
- •are using an effective method of birth control during the protocol (e.g.
- •implants, combined oral contraceptives, injectables, some IUDs, sexual
- •abstinence or vasectomised partner)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.subject has a critical condition defined as:
- •FEV1 < 30% and / or
- •SaO2 < 93% without O2-substitution; need of O2-substitution
- •2.Subject had an ENT surgery within 3 months prior to study
- •3.Subject shows signs of nasal bleeding
- •4.Subject has an ear drum perforation
- •5.Subject had an acute rhinosinusitis or a pulmonary exacerbation at study
- •entry with need of additional systemic antibiotic therapy against
- •pseudomonas aerug.
- •6.Subject is unlikely to comply with the procedures scheduled in the protocol
- •7.Subject has a known allergic reaction to the medication
- •8.Subject is pregnant or breastfeeding
- •9.Subject participates in another clinical trial within 30 days prior to study
- •entry or 30 days after end of the study.
- •10.Systemic (oral or intravenous) antibiotic treatment against P.a. 14 days
- •prior to the inclusion and during the study
- •11.If serum level of tobramycin is above 2 mg/l one hour after inhalation,
- •subject has to withdraw the participation in the study.
- •12.progressed renal insufficiency
- •13.severe damage of the N. acusticus
- •14.dissiness (potential damage of N. vestibularis)
研究者
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