Onbrez Breezhaler indacaterol: Phase III data

In the double-blind, international Phase III INSIST trial in 1,123 patients ages 40 and older, 150 µg once-daily indacaterol was superior to 50 µg twice-daily salmeterol on the primary endpoint of significantly improving FEV1 AUC from 5 minutes to 11 hours 45 minutes post-dose at week 12. Specifically, the adjusted mean difference in FEV1 AUC between treatment groups was 60 mL (p<0.001). Additionally, indacaterol was superior to salmeterol on the secondary endpoints of significantly improving trough FEV1 (p<0.001) and transition dyspnea index total score (p<0.001) at week 12. Furthermore, a significantly greater proportion of patients receiving indacaterol achieved a >=1 point improvement from baseline in transition dyspnea index total score vs. salmeterol (69.4% vs. 62.7%, p<0.05). Indacaterol also significantly increased the number of days in which patients required no rescue medication vs. salmeterol (p<0.05).

Indacaterol was well tolerated with a similar overall incidence of adverse events between treatment groups (33.8% vs. 33.5%). The most common adverse event for the indacaterol and salmeterol arms was COPD worsening (4.5% vs. 5.7%). Overall, 3.6% of indacaterol-treated patients experienced a serious adverse event vs. 2.8% for salmeterol. Two deaths in the indacaterol arm and 1 death in the salmeterol arm were reported, none of which were suspected to be related to treatment. Data were presented at the European Respiratory Society meeting in Barcelona. ...