Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)
Status:
Completed
Trial end date:
2008-02-27
Target enrollment:
Participant gender:
Summary
A major factor in the respiratory health of cystic fibrosis (CF) subjects is acquisition of
chronic Pseudomonas aeruginosa infections. The infection rate with P. aeruginosa increases
with age and by age 18 years, 80% of CF subjects in the U.S. are infected. Liposomal Amikacin
for Inhalation (Arikace™) is a sterile aqueous liposomal suspension consisting of amikacin
sulfate encapsulated in liposomes. This formulation of amikacin maximizes the achievable dose
and delivery to the lungs of subjects infected via a nebulizer. Because liposome particles
are small enough to penetrate and diffuse through sputum into the bacterial biofilm, they
deposit drug in close proximity to the bacterial colonies, thus improving the bioavailability
of amikacin at the infection site. The clinically achievable doses of amikacin in the LAI
formulation can effectively increase the half-life of the drug in the lungs, and decrease the
potential for systemic toxicity. LAI offers several advantages over current therapies in
treating CF subjects with chronic infection caused by P. aeruginosa.