drugset / Trial / NCT00391976

Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis

NCT00391976

Phase 3 Completed 123 enrolled Novartis
RandomizedParallel-groupOpen-labelTreatment

Summary

This study assessed time to recurrence of infection with Pseudomonas aeruginosa following treatment of the initial infection with tobramycin nebuliser solution. The safety profile of the initial tobramycin treatment was assessed during the first 3 months of the study and patients were followed until the end of the study, month 27.

Timeline

Start
2003-11
Primary completion
2008-01
Completion
2008-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tobramycin Small molecule 300 mg Inhaled

Indications