At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating tobramycin / Bramitob and tobramycin / TOBI for Cystic Fibrosis. Completed, enrolled 324 participants across 44 sites in 8 countries.
Detailed 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.
Study Details
Timeline
Interventions
300mg/4ml solution, via a nebuliser, over a 4-week treatment in a twice-daily regimen
300mg/5ml solution administered via nebuliser, over a 4-week treatment in a twice-daily regimen