EUCTR2007-003628-39-IT进行中（未招募）不适用
Pilot study to evaluate the local tollerability and efficacy of a new tobramycin 3% nasal spray formulation to reduce the bacterial density of Pseudomonas aeruginosa and/or Staphylococcus aureus, in patients affected by Cystic Fibrosis with rhinosinusal infection - ND
ECUPHARMA S.R.L.0 个研究点开始时间: 2008年4月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •-Documented Cystic Fibrosis diagnosis based on the following: positive sweat test (chloride concentration = 60mEq/l or higher; two CF genotype mutations. -Documented nasal infection by Pseudomonas a. and/or Staphylococcus a. -Forced Expiratory Volume in one second (FEV1) that was at least 50% of the predicted value. - Age (6 to 22 years) -Compliant patients -Informed consent written provided by the patient and/or parent or legal tutor according to the current law.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Hypersensitivity to aminoglycosides -Burkholderia cepacia cronic infection -Pregnancy and lactation -Septal deviation -Current and recurrent epistaxis -Rhinosinusal polypose -Endoscopic nasal surgery during the previous 6 months -Systemic antibiotic administration during the 30 days before the study or during it -Documented periodic or aperiodic allergic rhinitis
研究者
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