A major factor in the respiratory health of Cystic Fibrosis (CF) subjects is the prevalence
of chronic Pseudomonas aeruginosa infections. The Pseudomonas aeruginosa infection rate in CF
patients increases with age and by age 18 years approximately 85% of CF patients in the US
are infected. Liposomal amikacin for inhalation (Arikace™) was developed as a possible
treatment for chronic infection due to Pseudomonas aeruginosa in CF patients.
The purpose of this double-blind, placebo controlled study is to determine whether Arikace™
is effective in treating chronic lung infections caused by Pseudomonas aeruginosa in Cystic
Fibrosis subjects. The study will enroll approximately 300 subjects in clinics in the US,
Canada, Europe, Australia and New Zealand. Subjects will be randomized to 590 mg Arikace™ or
placebo and will receive treatment for 28 days followed by a 56 day safety follow-up period.
The subjects will be required to visit the clinic 8 times (including the Screening visit)
over a period of approximately 3 months. No overnight stays at the clinic will be required.
At the completion of the TR02-109 protocol, subjects who have consented and meet study safety
criteria may enroll in the long-term, open-label, multi-cycle extension study of 590 mg of
Arikace™ (under a separate protocol TR02-110).