GSK/Theravance announce results of four Phase III studies of GSK 573719 plus vilanterol in COPD - 09-Jul-2012

GSK and Theravance announced results of four pivotal Phase III studies of GSK 573719 (umeclidunium bromide) ("UMEC"),a long acting muscarinic antagonist (LAMA) and vilanterol, a long acting beta agonist (LABA) ("VI") administered by dry powder inhaler for treatment of COPD.The results of the four pivotal phase III studies of UMEC/VI involved over 4,000 patients with chronic obstructive pulmonary disease (COPD). These four studies include two 24-week efficacy studies that compared the combination, its components and placebo and two 24-week active comparator studies that compared the combination with the LAMA tiotropium, a widely prescribed maintenance bronchodilator for COPD.1. The first 24-week, randomised, double-blind, placebo-controlled study evaluated the efficacy and safety of UMEC/VI 125/25mcg, VI 25mcg, UMEC 125mcg and placebo. This study randomised 1,493 patients. For the pre-specified primary endpoint of trough FEV1 at the end of the treatment period (Day 169), this study showed statistically significant improvements for UMEC and VI individually compared to placebo (p<0.001). The combination UMEC/VI showed statistically significant improvements when compared with the individual components UMEC and VI (p<0.001) and when compared to placebo (238mL, p<0.001).2. The second 24-week, randomised, double-blind, placebo-controlled study evaluated the efficacy and safety of UMEC/VI 62.5/25mcg, VI 25mcg, UMEC 62.5mcg and placebo. This study randomised 1,536 patients. For the pre-specified primary endpoint of trough FEV1 at the end of the treatment period (Day 169), this study showed statistically significant improvements for UMEC and VI individually compared to placebo (p<0.001). The combination UMEC/VI showed statistically significant improvements when compared with the individual components UMEC and VI (p=0.004) and when compared to placebo (167mL, p<0.001). 3.The first 24-week, randomised, double-blind, double-dummy, parallel-group study compared the efficacy and safety of UMEC/VI 62.5/25mcg and 125/25mcg with VI 25mcg and tiotropium 18mcg. This study randomised 846 patients. For the pre-specified primary endpoint of trough FEV1 at the end of the treatment period (Day 169), this study showed statistically significant improvements for both doses of UMEC/VI compared with VI (88-90mL, p<0.001) and tiotropium (88-90mL, p<0.001). 4.The second 24-week, randomised, double-blind, double-dummy, parallel-group study compared the efficacy and safety of UMEC/VI 62.5/25mcg and 125/25mcg with UMEC 125mcg and tiotropium 18mcg. This study randomised 872 patients. The pre-specified primary endpoint was trough FEV1 at the end of the treatment period (Day 169). For the first treatment comparison, UMEC/VI 125/25mcg showed a statistically significant improvement of 74mL compared with tiotropium (p=0.003). For the second comparison, UMEC/VI 125/25mcg showed a numerical but not statistically significant improvement (37mL) compared with UMEC 125mcg (p=0.142). UMEC/VI 62.5/25mcg showed a numerical difference from tiotropium of 60mL (p=0.018) and a numerical difference from UMEC 125mcg of 22mL (p=0.377) in trough FEV1. placebo. The incidence of cardiovascular adverse events across all treatment groups was similar.