Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection

This open-label extension study examined the long-term safety, tolerability, and efficacy of amikacin liposome inhalation suspension in 206 patients with cystic fibrosis and chronic Pseudomonas aeruginosa infection over a period of ~2 years. The primary endpoints of the study were as follows: treatment-emergent adverse events, serious adverse events, and laboratory abnormalities up to Day 672; adverse events resulting in discontinuation of study treatment; acute tolerability (ie pre-dose to post-dose change in pulmonary function); baseline and pre-dose to post-dose change in vital signs and oxygen saturation; change in serum creatinine; minimum inhibitory concentration shifts for P. aeruginosa from Day 1 to Days 169, 337, 505, and 672; and audiology. Clinical trial services were provided by Vitalograph.