Conclusions
This study was designed to evaluate the efficacy and safety of 4 doses of GP MDI so that the dose(s) that produce a consistent 12- and/or 24-hour duration of action can be selected for more definitive studies (phase 2b/phase 3). Glycopyrronium MDI 14.4, 28.8, 57.6, and 115.2 μg demonstrated statistically significant and clinically relevant superior bronchodilator efficacy compared with Placebo MDI in study patients with mild to moderate COPD. The overall profile of GP MDI based on 12-hr post-dose FEV1 compared with 24-hr post-dose tFEV1, and AUC0–12 compared with AUC12–24 support a BID dosing regimen at all doses evaluated. These same comparisons confirmed TIO as a QD drug. Based on the results of the current study, the candidate doses of GP MDI for further evaluation were total daily doses of 57.6 or 115.2 μg, administered as 28.8 or 57.6 μg given BID.