Fixed combination of glycopyrrolate and formoterol MDI (GFF-MDI) demonstrates superior inspiratory capacity (IC) compared to tiotropium DPI (Tio) following 7 days dosing, in a randomized, double-blind, placebo-controlled phase 2b study in patients with COPD

Rationale: In COPD, IC is inversely correlated to dyspnea with exercise. Tio is an inhaled anticholinergic that improves IC. GFF-MDI is an inhaled bronchodilator comprised of glycopyrrolate and formoterol fumarate. Pearl evaluated improvements in IC of GFF-MDI compared to Tio and placebo (PL) following chronic dosing in a large Phase IIb study. Methods: Randomized, double-blind, customized, unbalanced, incomplete block, crossover study was conducted in patients with moderate to very severe COPD. One objective was to assess changes in IC on Day7 between 2 doses of GFF-MDI, Tio and PL. MDIs were administered BID for 1 week; Tio was administered QD for 1 week. Results: 118 patients randomized. GFF-MDI (72/9.6 and 36/9.6 μg) and Tio were superior to Pl on morning pre-dose trough assessments (255mL, 271mL and 166mL, respectively; P≤0.0004 all comparisons) and for Peak IC assessments (265mL, 293mL and 170 mL, respectively; P≤ 0.0016 all comparisons). Both GFF-MDI 72/9.6 μg and GFF-MDI 36/9.6 μg were superior to Tio for pre-dose trough IC (90mL and 105mL, respectively; P Conclusion: Both doses of GFF-MDI were superior to PL and Tio for morning pre-dose and Peak IC assessments. These findings support the further development of GFF-MDI in patients with COPD.