Olodaterol/tiotropium: Phase III data

Pooled data from about 5,163 COPD patients total in the double-blind, international Phase III TONADO 1 and 2 trials showed that once-daily 5/5 Ug olodaterol/tiotropium met the co-primary endpoint of improving FEV1 AUC from 0-3 hours at week 24 vs. tiotropium alone (relative difference of 110 mL, p<0.001) and olodaterol alone (relative difference of 128 mL, p<0.001). Additionally, olodaterol/tiotropium met the second co-primary endpoint of improving trough FEV1 at week 24 vs. tiotropium alone (relative difference of 60 mL, p<0.001) and olodaterol alone (relative difference of 85 mL, p<0.001). Furthermore, olodaterol/tiotropium met the third co-primary endpoint of reducing SGRQ score from baseline to week 24 vs. tiotropium alone (relative difference of 1.233 points, p=0.0252) and olodaterol alone (relative difference of 1.693 points, p=0.0022). Boehringer did not disclose data for the 2.5/5 Ug dose of olodaterol/tiotropium. The combination was delivered via the company's Respimat Soft Mist Inhaler. Data were presented at the European Respiratory Society meeting in Munich. ...