Randomized, open labelled, cross over deposition study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in subjects with CF

PARI GmbH0 个研究点目标入组 25 人开始时间: 2007年4月4日最近更新: 2012年3月19日

研究概览

暂无简介。

•Male and female subjects with CF >/= 10 years of age
•Stable condition with no exacerbation requiring IV antibiotics or hospitalization within a three month period prior to screening visit
•Ability to perform reproducible spirometry
•Room air oximetry >/= 92% saturation
•Stable doses of antibiotics and systemic steroids in the last 3 months
•Documented presence of P. aeurginosa infection in the lungs within the past year
•Regular use of inhaled tobramycin within the past year
•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

•Use of investigational medications within 30 days before study entry or during the trial.
•FEV1 • Significant Hemoptysis (eg >60 cc at any time within thirty days prior to study drug administration Or resulting in hospital admission
•Suspected or proven allergic bronchopulmonary aspergillosis (ABPA)
•Known local or systemic hypersensitivity to aminoglycosides.
•Serum creatinine > 175 µmol/l or a BUN > 15 mmol/l or ? 2+ proteinuria
•Significant liver disease (as evidenced by thrombocytopenia (platelet count < 150,000 per microliter) or hypoalbuminemia (albumin < 35 g/l) or the suspected presence of esophageal varicies
•Subjects with history of GI bleeding
•New development of CF related diabetes
•Presence of B. cepacia

发起方

PARI GmbH