Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections
Status:
Completed
Trial end date:
2013-09-18
Target enrollment:
Participant gender:
Summary
A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the
prevalence of chronic Pseudomonas aeruginosa (Pa) infections. The Pa 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 (Arikayce™) was developed as a possible
treatment for chronic infection due to Pa in CF patients.
The purpose of this study is to determine whether Arikayce™ is effective in treating chronic
lung infections caused by Pa in CF participants. The effectiveness, safety, and tolerability
of Arikayce™ will be compared to Tobramycin TOBI®, an inhalation antibiotic already available
for use.