TY - JOUR T1 - 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 JF - European Respiratory Journal JO - Eur Respir J VL - 38 IS - Suppl 55 SP - p879 AU - Colin Reisner AU - Earl St. Rose AU - Shannon Strom AU - Tracy Fischer AU - Michael Golden AU - Mervyn Thomas AU - Chadwick Orevillo Y1 - 2011/09/01 UR - http://erj.ersjournals.com/content/38/Suppl_55/p879.abstract N2 - 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<0.05 both doses) and Peak IC on Day 7 (95mL and 124mL, respectively; P<0.05 both doses).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. ER -