Conditions: Cystic Fibrosis
Keywords: cystic fibrosis P. aeruginosa tobramycin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 324
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: tobramycin / Bramitob administered 300mg twice a day for 4 weeks arm 2: tobramycin / TOBI administered 300mg twice a day for 4 weeks

Interventions: intervention 1: tobramycin / Bramitob intervention 2: tobramycin / TOBI
Intervention descriptions: intervention 1: 300mg/4ml solution, via a nebuliser, over a 4-week treatment in a twice-daily regimen intervention 2: 300mg/5ml solution administered via nebuliser, over a 4-week treatment in a twice-daily regimen

Protocol document: