Denufosol tetrasodium: Additional Phase III data

A post hoc subgroup analysis of 71 patients who were taking 0-2 classes of concomitant medications for CF in the double-blind, U.S. Phase III TIGER-1 trial showed that denufosol non-significantly improved FEV1 from baseline to week 24 vs. placebo (p=0.059). Denufosol did significantly improve percent predicted FEV1 (p=0.011) and forced expiratory flow 25-75% (p=0.041), which measures small airway function, vs. placebo at week 24. Patients received thrice-daily 60 mg inhaled denufosol or placebo for 24 weeks. Data were presented at the European Respiratory Society meeting in Barcelona. ...