Glaxosmithkline Plc And Theravance, Inc. Announces Positive Results From Four Pivotal Phase III Studies For Once-daily LAMA/LABA (UMEC/VI) In COPD

Glaxosmithkline Plc and Theravance, Inc. announced the results of four pivotal phase III studies of investigational LAMA/LABA involving over 4,000 patients with chronic obstructive pulmonary disease (COPD). These four studies include two 24-week efficacy studies that compared the combination LAMA/LABA, 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. LAMA/LABA is a combination of two investigational bronchodilator molecules - GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered by a new dry powder inhaler. 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). These data form part of the overall evaluation of the efficacy and safety of the UMEC/VI combination and the individual components in approximately 6,000 COPD patients. The ongoing registration programme includes a 52-week safety study and two replicate 12-week crossover exercise studies.