A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease

Table 2 FEV₁ AUC_0–12 at Day 7: GFF MDI 72/9.6 μg and 36/9.6 μg comparisons (mITT population)

	LSM treatment differences for GFF MDI in FEV₁ AUC_0–12 at Day 7
	GFF MDI		GP MDI 36 μg	Open-label tiotropium 18 μg	FF MDI		Placebo MDI	Open-label FF^a DPI 12 μg
Comparator	72/9.6 μg	36/9.6 μg	GP MDI 36 μg	Open-label tiotropium 18 μg	9.6 μg	7.2 μg	Placebo MDI	Open-label FF^a DPI 12 μg
GFF MDI 72/9.6 μg
LSM^b difference (SE), L	NA	0.008 (0.0236)	0.109 (0.0250)^†	0.103 (0.0216)^†	0.116 (0.0245)^†	0.124 (0.0237)^†	0.298 (0.0261)^†	0.101 (0.0241)^†
95% CI	NA	−0.039, 0.054	0.059, 0.158^c	0.060, 0.145	0.068, 0.165	0.078, 0.171	0.247, 0.349	0.053, 0.148
GFF MDI 36/9.6 μg
LSM^b difference (SE), L	See above	NA	0.101 (0.0245)^†	0.095 (0.0213)^†	0.109 (0.0242)^†	0.116 (0.0236)^†	0.290 (0.0261)^†	0.093 (0.0241)^***
95% CI	See above	NA	0.053, 0.149	0.053, 0.137	0.061, 0.156	0.070, 0.163	0.239, 0.342	0.045, 0.140

^*** p < 0.001; ^† p < 0.0001
^aForadil^® Aerolizer^®; ^bLSM allows for any imbalances in baseline covariates that relate to responses to be adjusted for in order to avoid bias in treatment effect estimates; ^cnon-inferiority comparison
CI, confidence interval; DPI, dry powder inhaler; FEV₁ AUC_0–12, forced expiratory volume in 1 s area under the curve from 0 to 12 h post-dose; FF, formoterol fumarate; GFF, glycopyrrolate/formoterol fumarate; GP, glycopyrrolate; LSM, least squares mean; MDI, metered dose inhaler; mITT, modified intent-to-treat; NA, not available; SE, standard error

ISSN: 1465-993X