This is an open-label, single arm (uncontrolled) study in patients suffering from cystic fibrosis;who have completed their study participation in extension study one CTBM100C2303E1.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Pulmonary InfectionsPseudomonas Aeruginosa
- Registration Number
- CTRI/2011/09/002020
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 140
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 patients with P. aeruginosa infection.
FEV1 at screening (at start of study CTBM100C2303) must be between 25 percentage and 80 percentage 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method