BioCentury
ARTICLE | Clinical News

Cayston aztreonam lysine: Phase III data

June 21, 2010 7:00 AM UTC

In the open-label, U.S. and European Phase III Study 205-0110 trial in 268 patients, Cayston met the co-primary endpoint of non-inferiority to inhaled tobramycin in mean percent change from baseline in percent predicted FEV1 at day 28 (8.35% vs. 0.55% increases, p=0.0001). Data on the other co-primary endpoint, superiority to inhaled tobramycin in mean change in percent predicted FEV1 across 3 treatment cycles, will be presented later this year. Cayston also led to significantly greater mean changes from baseline to day 28 in CFQ-R respiratory symptoms score vs. inhaled tobramycin (8.02 vs. 2.49 points, p=0.005). Data were presented at the European Cystic Fibrosis meeting in Valencia. ...