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GlaxoSmithKline and Theravance reported Monday positive headline results from four late-stage studies investigating a combination of the long-acting muscarinic antagonist (LAMA) umeclidinium bromide and the long-acting beta-agonist (LABA) vilanterol in patients with chronic obstructive pulmonary disease (COPD). Darrell Baker, senior vice president respiratory portfolio optimisation leader at GlaxoSmithKline, said that "subject to successful completion of the ongoing studies, we plan to commence global regulatory filings from the end of this year" for the once-daily medicine.
The 24-week trials involved more than 4500 patients with COPD and compared the umeclidinium bromide/vilanterol combination, its individual components alone and placebo, as well as versus Pfizer and Boehringer Ingelheim's LAMA Spiriva (tiotropium). Baker remarked that the combination therapy, which is administered by a dry powder inhaler and is under development for the maintenance treatment of COPD, is "an important cornerstone of our broad respiratory development portfolio."
GlaxoSmithKline and Theravance noted that two studies comparing the umeclidinium bromide/vilanterol combination, its individual components alone and placebo, met their main goals of improvements in trough FEV1 at the end of the treatment period. In both trials, which included a total of more than 3000 patients, umeclidinium bromide and vilanterol alone showed significant improvements in trough FEV1 compared to placebo. Further, in the two studies, the combination therapy demonstrated significant improvements in trough FEV1 versus the individual components alone and when compared to placebo.
A third trial compared umeclidinium bromide/vilanterol with vilanterol and Spiriva in 846 patients. Results showed that for the primary endpoint of improvement in trough FEV1 at the end of the treatment period, significant improvements were seen for both doses of the combination medicine compared with vilanterol and Spiriva. In the final study, 872 patients received umeclidinium bromide/vilanterol, umeclidinium bromide or Spiriva. GlaxoSmithKline and Theravance said that for the main goal of trough FEV1 at the end of the treatment period, umeclidinium bromide/vilanterol showed a significant improvement compared with Spiriva. Further, although the combination medicines showed a numerical improvement versus umeclidinium bromide, the result was not significant.
GlaxoSmithKline and Theravance indicated that full results from the studies will be presented at upcoming medical meetings. The drugmakers are also conducting a 52-week safety study and two 12-week crossover exercise studies of the umeclidinium bromide/vilanterol combination. The data from these studies is also expected to be used in regulatory submissions for GlaxoSmithKline’s umeclidinium bromide monotherapy, with filings planned for next year.
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