Open Label Extension to Bridging Study CTBM100C2303
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pseudomonas Aeruginosa; Cystic Fibrosis
Intervention: Tobramycin inhalation powder (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Pharmaceuticals
Summary
This is an open-label, single arm (uncontrolled) study in subjects suffering from cystic
fibrosis, who have completed their study participation in CTBM100C2303 (all visits) and who
were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.
Clinical Details
Official title: A Phase III Open-label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Safety of tobramycin inhalation powder for the treatment of infections with P. aeruginosa in subjects suffering from cystic fibrosis.
Secondary outcome: Efficacy of tobramycin inhalation powder, assessed by spirometryDensity of microorganisms in sputum samples
Eligibility
Minimum age: 6 Years.
Maximum age: 21 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 patients with P. aeruginosa infection.
- FEV1 at screening (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 core
trial CTMB100C2303 and the enrollment into this study.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Locations and Contacts
Novartis Investigative Site, Tallin, Estonia
Novartis Investigative Site, Yaroslavl, Russian Federation
Additional Information
Starting date: August 2009
Last updated: May 2, 2012
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