Table 3.

Secondary Patient-Reported Outcome Endpoints (China ITT Population/China Symptomatic Population)

	China ITT Population				China Symptomatic Populationa
	GFF MDI 18/9.6 µg	GP MDI 18 µg	FF MDI 9.6 µg	Placebo MDI	GFF MDI 18/9.6 µg	GP MDI 18 µg	FF MDI 9.6 µg	Placebo MDI
TDI focal score over 24 weeksb
n	142	119	129	59	43	37	39	15
LSM (SE)	2.5 (0.16)	2.0 (0.18)	2.3 (0.17)	1.4 (0.25)	2.2 (0.32)	1.7 (0.34)	2.1 (0.33)	1.0 (0.54)
Treatment difference for GFF MDI vs monocomponents and placebo MDI
LSM	NA	0.42	0.20	1.11	NA	0.46	0.10	1.22
95% CI	NA	−0.05, 0.89	−0.26, 0.66	0.52, 1.69	NA	−0.46, 1.38	−0.81, 1.01	−0.02, 2.45
P-value	NA	0.0780	0.3924	0.0002	NA	0.3234	0.8267	0.0543
Change from baseline in SGRQ total score at Week 24
n	129	110	116	53	38	34	35	13
LSM (SE)	−8.5 (0.97)	−7.3 (1.05)	−9.4 (1.02)	−5.3 (1.51)	−12.0 (2.17)	−12.3 (2.33)	−13.7 (2.28)	−7.0 (3.75)
Treatment difference for GFF MDI vs monocomponents and placebo MDI
LSM	NA	−1.21	0.87	−3.24	NA	0.26	1.70	−5.04
95% CI	NA	−4.02, 1.61	−1.90, 3.64	−6.76, 0.28	NA	−6.05, 6.57	−4.54, 7.94	−13.66, 3.58
P-value	NA	0.3996	0.5373	0.0714	NA	0.9352	0.5894	0.2489

Notes: ^aThe China symptomatic population was defined as patients in the China ITT population with a CAT score ≥15 at screening. ^bTDI focal score over 24 weeks was based on assessments at Weeks 4, 8, 12, 16, 20, and 24. All p-values <0.05 should only be interpreted in terms of nominal significance as the analyses in the Chinese subgroup were considered exploratory.

Abbreviations: CAT, COPD Assessment Test; CI, confidence interval; COPD, chronic obstructive pulmonary disease; FF, formoterol fumarate; GFF, glycopyrrolate/formoterol fumarate; GP, glycopyrrolate; ITT, intent-to-treat; LSM, least squares mean; MDI, metered dose inhaler; NA, not applicable; SE, standard error; SGRQ, St George’s Respiratory Questionnaire; TDI, Transition Dyspnea Index.