LONDON (dpa-AFX) - GlaxoSmithKline Plc (GSK, GSK.L) and Theravance, Inc. (THRX) announced the results of four pivotal phase III studies of investigational LAMA/LABA involving over 4,000 patients with chronic obstructive pulmonary disease, or 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.
The first 24-week, randomised, double-blind, placebo-controlled study assessed 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 versus placebo. The combination UMEC/VI showed statistically significant improvements when compared with the individual components UMEC and VI and when compared to placebo.
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. The combination UMEC/VI showed statistically significant improvements when compared with the individual components UMEC and VI and when compared to placebo.
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 and tiotropium.
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. For the second comparison, UMEC/VI 125/25mcg showed a numerical but not statistically significant improvement compared with UMEC 125mcg. UMEC/VI 62.5/25mcg showed a numerical difference from tiotropium of 60mL and a numerical difference from UMEC 125mcg of 22mL in trough FEV1.
Copyright RTT News/dpa-AFX
© 2012 AFX News
