Phase 3 Study Update of Umeclidinium Bromide/Vilanterol (UMEC/VI) for COPD

GlaxoSmithKline and Theravance announced the results of four pivotal Phase 3 studies of umeclidinium bromide/vilanterol (UMEC/VI) in 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 tiotropium (Spiriva Handihaler; Boehringer Ingelheim) for the maintenance treatment of COPD.

The first 24-week, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of UMEC/VI 125/25mcg, VI 25mcg, UMEC 125mcg and placebo.  This study randomized 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).

The second 24-week, randomized, 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 randomized 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).

The first 24-week, randomized, 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 randomized 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).

The second 24-week, randomized, 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 randomized 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.

Umeclidinium bromide is a long-acting muscarinic antagonist.  Vilanterol is a long-acting beta2 agonist. 

For more information visit www.gsk.com or www.theravance.com.