Long term safety and tolerability of open-label liposomal amikacin for inhalation (Arikace™) in cystic fibrosis patients with chronic infection due to Pseudomonas aeruginosa
This phase 3 trial (NCT01316276) was conducted in 75 centers in 17 countries in Europe and Canada to evaluate the long-term safety, tolerability, and efficacy of up to 6 cycles of liposomal amikacin for inhalation (LAI) treatment in patients previously treated with LAI and tobramycin inhalation solution (TIS) (CLEAR-108 study). Of the 266 patients who completed the CLEAR-108 study, 206 patients (including 92 on prior LAI and 114 on prior TIS treatment) were enrolled. At the end of the sixth off-treatment cycle of the present study, FEV1 showed sustained improvement above baseline values, with a relative mean change of 3.39% and 1.11% for patients previously treated with LAI and TIS, respectively. Patients who previously received LAI in CLEAR-108 appeared to have a sustained improvement in FEV1 with longer-term exposure. Overall, reductions in P. aeruginosa sputum density were similar in all patients regardless of prior treatment. LAI had a favorable tolerability profile with prolonged exposure, with most adverse events being respiratory in nature.
12 ECFS-CTN sites in country A, B and C participated in this study and enrolled 33 of the patients.
The summary of data provided here are from the presentation of the study results at the North American Cystic fibrosis Conference in Atlanta (GA, USA) in October 2014.