Boehringer's olodaterol/tiotropium meets in Phase III COPD trial

Boehringer Ingelheim GmbH (Ingelheim, Germany) said fixed-dose combinations of once-daily olodaterol/tiotropium met the primary endpoint vs. olodaterol or tiotropium monotherapy and placebo in the Phase III VIVACITO trial to treat chronic obstructive pulmonary disease (COPD). The primary endpoint was change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve (AUC) over 0-24 hours at week six (p<0.0001 for all). The double-blind, international trial enrolled 219 patients with moderate to very severe COPD to receive once-daily 2.5/5 ug or 5/5 ug olodaterol/tiotropium, 5 ug olodaterol as monotherapy, 2.5 or 5 ug tiotropium as monotherapy or placebo. Data were presented at the American Thoracic Society meeting in San Diego.

Data from additional trials in the Phase III program of the olodaterol/tiotropium combination are expected this year. The product is a once-daily fixed-dose combination of the company's olodaterol, a long-acting beta 2 agonist (LABA), and Spiriva tiotropium, a long-acting muscarinic antagonist (LAMA) delivered via Boehringer's Respimat Soft Mist Inhaler. ...