Table 2.

Primary and secondary lung function endpoints (ITT population)

	GFF MDI 18/9.6 μg	GP MDI 18 μg	FF MDI 9.6 μg	Placebo MDI
Primary endpoint
Change from baseline in morning predose trough FEV1 at Week 24 (mL)
n	488	412	413	196
LSM	120	60	47	−45
SE	9.1	9.9	9.9	14.3
Treatment difference for GFF MDI vs monocomponents and placebo MDI
LSM (95% CI)	NA	59 (33, 86)	72 (46, 99)	165 (132, 198)
P-value	NA	<0.0001a	<0.0001a	<0.0001a
Secondary endpoints
Change from baseline in morning predose trough FEV1 over 24 weeksb (mL)
n	541	465	467	225
LSM	135	80	63	−20
SE	7.0	7.6	7.6	10.9
Treatment difference for GFF MDI vs monocomponents and placebo MDI
LSM (95% CI)	NA	55 (35, 76)	72 (52, 92)	155 (129, 180)
P-value	NA	<0.0001a	<0.0001a	<0.0001a
Peak change from baseline in FEV1 within 2 hours postdosing at Week 24 (mL)
n	490	412	413	196
LSM	358	214	247	55
SE	10.2	11.1	11.1	16.0
Treatment difference for GFF MDI vs monocomponents and placebo MDI
LSM (95% CI)	NA	145 (115, 174)	111 (81, 140)	303 (266, 340)
P-value	NA	<0.0001a	<0.0001a	<0.0001a

Notes:

^aStatistically significant/superior.

^bMorning predose trough FEV₁ over 24 weeks was based on assessments at Weeks 2, 4, 8, 12, 16, 20, and 24.

Abbreviations: 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.