GSK/Theravance announce results of four Phase III studies of GSK 573719 plus vilanterol in COPD

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 1536 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.>