Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase
Status:
Completed
Trial end date:
2010-11-02
Target enrollment:
Participant gender:
Summary
A major factor in the respiratory health of cystic fibrosis (CF) patients is acquisition of
chronic Pseudomonas (P.) aeruginosa infections. The infection rate with P. aeruginosa
increases with age and by age 18 years, 80% of patients with CF in the U.S. are infected.
Liposomal amikacin for inhalation (LAI; Arikayce™) 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 infected patients when delivered
via a nebulizer. Because liposome particles are small enough to penetrate and diffuse through
sputum into the bacterial biofilm, they deposit drug close to the bacterial colonies (Meers,
et al., 2008) (Clancy, et al., 2013), 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 patients
with CF with chronic infection caused by P. aeruginosa.