Clinical Trial: Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Nasal Inhalation of Tobramycin by the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization in the Upper Airways
Brief Summary: 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.
Detailed Summary:
Sponsor: University of Jena
Current Primary Outcome: Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid [ Time Frame: day -1, 1, 29, 30, 59, 60 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Measure of serum levels of tobramycin [ Time Frame: day 1, 30 and 60 ]
- Tolerability [ Time Frame: day 1, 30 and 60 ]
Original Secondary Outcome: Measure of serum levels of tobramycin [ Time Frame: day 1, 30 and 60 ]
Information By: University of Jena
Dates:
Date Received: October 16, 2008
Date Started: October 2008
Date Completion:
Last Updated: December 3, 2014
Last Verified: December 2014
