Status:
COMPLETED
Open Label Extension to Bridging Study CTBM100C2303
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Pseudomonas Aeruginosa
Cystic Fibrosis
Eligibility:
All Genders
6-21 years
Phase:
PHASE3
Brief Summary
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who had completed their study participation in CTBM100C2303 (all visits) and who were proven inf...
Eligibility Criteria
Inclusion
- Completed all visits in study CTBM100C2303, and visit 4 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 (study CTBM100C2303) must be between 25% and 80% of normal predicted values.
Exclusion
- Any use of inhaled anti-pseudomonal antibiotics between the termination of the core trial CTMB100C2303 and the enrollment into this study.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Key Trial Info
Start Date :
August 12 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2011
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00982930
Start Date
August 12 2009
End Date
October 6 2011
Last Update
June 2 2021
Active Locations (2)
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1
Novartis Investigative Site
Tallinn, Estonia
2
Novartis Investigative Site
Yaroslavl, Russia