Second Open Label Extension to Bridging Study CTBM100C2303

• Status: Completed
• Trial end date: 2012-03-19
• Target enrollment: 0
• Participant gender: All

Summary

This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Tobramycin

Criteria

Inclusion Criteria:

• Completed all visits in study CTBM100C2303 and CTBM100C2303E1, and visit 11 of study CTBM100C2303E1 took place not more than 5 days before enrollment into this study.

• Confirmed diagnosis of cystic fibrosis participants with P. aeruginosa infection.

• Forced Expiratory Volume in one second (FEV1) at screening (at start of study CTBM100C2303) must be between 25% and 80% of normal predicted values.

Exclusion Criteria:

• Any use of inhaled anti-pseudomonal antibiotics between the termination of the trial CTMB100C2303E1 and the enrollment into this study.

• Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.