A large Phase IIb COPD dose-optimization study with the lead long-acting beta agonist (LABA) GW642444 (‘444) has commenced, with screening of the first patient undertaken. This double-blind, placebo controlled trial will enroll approximately 600 patients with moderate to severe COPD from study centers across the US, Europe and international locations. Each patient will be randomized to receive a once-daily dose of placebo or ‘444 via a novel inhaler throughout the 28-day treatment period. The primary endpoint of the study will be efficacy, evaluated by change from baseline FEV1 (pre-bronchodilator and pre-dose) at the end of the 28-day treatment period, with a number of secondary endpoints also evaluated.
These study data, taken together with the data obtained from parallel studies currently being undertaken with ‘698, will be used to guide future development plans in COPD and progression into large-scale Phase III COPD combination studies.
Rick Winningham, CEO of Theravance, said: “With ‘444 now in large Phase IIb studies in both asthma and COPD, we have met two important targets that bring us closer to our joint goal of bringing a new treatment option to patients in these important therapeutic areas.”