A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI® (CT03Ext)

Chiesi

Status and phase: Completed; Phase 3

Conditions: Cystic Fibrosis

Treatments: Drug: tobramycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01111383

CMA-0631-PR-0010 Extension

Details and patient eligibility

About

This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if deemed appropriate by the Investigators will be able to be included in the 48-week follow-on period (Extension Study) to continue the treatment only with Bramitob® (tobramycin nebuliser solution, 300 mg twice daily in 4 mL unit dose vials).

Enrollment: 209 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Successful completion of Core Study
• At least 6 years of age
• Males and females

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)