Second 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: Pulmonary Infections; Pseudomonas Aeruginosa
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 patients 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.
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) Patients Who Completed Participation in Study CTBM100C2303E1.
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 patients suffering from cystic fibrosis.
Secondary outcome: Efficacy of tobramycin inhalation powder, assessed by FEV1 , FVC and FEF25-75 profile.Density 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 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% 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.
Locations and Contacts
Novartis Investigative Site, Pleven, Bulgaria
Novartis Investigative Site, Polvdiv, Bulgaria
Novartis Investigative Site, Sofia, Bulgaria
Novartis Investigative Site, Varna, Bulgaria
Novartis Investigative Site, Tallin, Estonia
Novartis Investigative Site, Tartu, Estonia
Novartis Investigative Site, Riga, Latvia
Novartis Investigative Site, Kaunas, Lithuania
Novartis Investigative Site, Vilnius, Lithuania
Novartis Investigative Site, Bucharest, Romania
Novartis Investigative Site, Timisoara, Romania
Novartis Investigative Site, Kazan, Russian Federation
Novartis Investigative Site, Moscow, Russian Federation
Novartis Investigative Site, Saint Petersburg, Russian Federation
Novartis Investigative Site, Samara, Russian Federation
Novartis Investigative Site, Yaroslavl, Russian Federation
Novartis Investigative Site, Durban, South Africa
Additional Information
Starting date: February 2010
Last updated: May 2, 2012
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