NCT00885365

A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®

A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare the safety in participants with cystic fibrosis and chronic infection of the lungs with Pseudomonas aeruginosa.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	tobramycin / Bramitob	300mg/4ml solution, via a nebuliser, over a 4-week treatment in a twice-daily regimen
DRUG	tobramycin / TOBI	300mg/5ml solution administered via nebuliser, over a 4-week treatment in a twice-daily regimen

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2009-04-21
• Last updated: 2018-06-27
• Results posted: 2014-06-20

Locations

44 sites across 8 countries: Czechia, France, Germany, Hungary, Poland, Russia, Spain, Ukraine