A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
Completed
Chiesi Farmaceutici S.p.A.
Phase 3
2009-04-01
The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is
non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one
second (FEV1) percent of predicted normal, and to compare the safety in participants with
cystic fibrosis and chronic infection of the lungs with Pseudomonas aeruginosa.
Observational Study in Cystic Fibrosis Patients Using TOBI® Podhaler™ or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs
Active, not recruiting
Cystic Fibrosis Foundation
2015-05-05
This is a multicenter, prospective, two cohort, observational study over a 5-year period in
Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection.The study will
collect data over 1 year on respiratory function, antibacterial effectiveness, and clinical
outcomes of treatment with inhaled antipseudomonal antibiotics and data over 5 years on
microbiological and safety assessments.
Observational Study in Cystic Fibrosis Patients Using TOBI® Podhaler™ or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs
Active, not recruiting
Cystic Fibrosis Foundation Therapeutics
2015-05-05
This is a multicenter, prospective, two cohort, observational study over a 5-year period in
Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection.The study will
collect data over 1 year on respiratory function, antibacterial effectiveness, and clinical
outcomes of treatment with inhaled antipseudomonal antibiotics and data over 5 years on
microbiological and safety assessments.
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