GlaxoSmithKline and Theravance announced the completion of the Phase 3 program of umeclidinium bromide/vilanterol (UMEC/VI) involving approximately 6,000 patients with chronic obstructive pulmonary disease (COPD).
On July 2, GSK and Theravance announced the completion of four pivotal studies for UMEC/VI. The pivotal program for UMEC/VI also includes a 52-week safety study, which is now complete. Two non-pivotal 12-week crossover exercise studies will also be included in the registrational package as they are now also complete. These recently completed studies support GSK’s plans to commence global regulatory submissions for UMEC/VI from the end of 2012.
The 52-week parallel group safety study evaluated the long-term safety and tolerability of UMEC 125mcg alone and the combination UMEC/VI 125/25mcg compared to placebo in approximately 500 patients. The two replicate 12‑week crossover exercise studies of approximately 300 patients each evaluated the lung function and exercise endurance time of UMEC/VI 125/25mcg and 62.5/25mcg, UMEC 125mcg and 62.5mcg, and VI 25mcg compared to placebo. The co-primary endpoints of these studies were 3‑hour post-dose exercise endurance time and trough FEV1.
Umeclidinium bromide is a long-acting muscarinic antagonist. Vilanterol is a long-acting beta2 agonist.