Amikacin liposome inhalation suspension for chronic Pseudomonas aeruginosa infection in cystic fibrosis.

ABSTRACT:

Background

Shortcomings of inhaled antibiotic treatments for Pseudomonas aeruginosa infection in patients with cystic fibrosis (CF) include poor drug penetration, inactivation by sputum, poor efficiency due to protective biofilm, and short residence in the lung.

Methods

Eligible patients with forced expiratory volume in 1 s (FEV₁) ≥25% of predicted value at screening and CF with chronic P. aeruginosa infection were randomly assigned to receive 3 treatment cycles (28 days on, 28 days off) of amikacin liposome inhalation suspension (ALIS, 590 mg QD) or tobramycin inhalation solution (TIS, 300 mg BID). The primary endpoint was noninferiority of ALIS vs TIS in change from baseline to day 168 in FEV₁ (per-protocol population). Secondary endpoints included ch

SUBMITTER: Bilton D 

PROVIDER: S-EPMC9078215 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature