Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years

A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years

This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.

Inclusion Criteria:

• Diagnosis of cystic fibrosis
• Early lower respiratory tract infection with P. aeruginosa,

Exclusion Criteria:

• Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
• Administration of loop diuretics within 7 days prior to study drug administration.
• Other protocol-defined inclusion/exclusion criteria may apply