Table 5.

0–12-hour and 12–24-hour weighted mean FEV ₁ (L) on Day 7, (a) morning and (b) evening dose (mITT population)

a.
Morning dose:		UMEC QD
0–12-hour	Placebo	15.6 μg	31.25 μg	62.5 μg	125 μg
weighted mean FEV 1 (L)	N = 60	N = 60	N = 57	N = 59	N = 60
N	54	58	52	56	56
LS mean (SE)	1.353 (0.019)	1.467 (0.019)	1.478 (0.020)	1.481 (0.019)	1.526 (0.019)
LS mean change (SE)	−0.046 (0.019)	0.068 (0.019)	0.078 (0.020)	0.082 (0.019)	0.126 (0.019)
Difference from placebo	N/A	0.114	0.124	0.128	0.172
95% CI	N/A	(0.066, 0.161)	(0.075, 0.173)	(0.079, 0.177)	(0.124, 0.220)
p-value	N/A	<0.001	<0.001	<0.001	<0.001
Morning dose:	UMEC BID				Tiotropium QD
0–12-hour	15.6 μg		31.25 μg		18 μg
weighted mean FEV 1 (L)	N = 56		N = 58		N = 56
N	52		55		53
LS mean (SE)	1.483 (0.020)		1.483 (0.019)		1.530 (0.020)
LS mean change (SE)	0.084 (0.020)		0.084 (0.019)		0.130 (0.020)
Difference from placebo	0.130		0.130		0.176
95% CI	(0.081, 0.178)		(0.081, 0.178)		(0.128, 0.224)
p-value	<0.001		<0.001		<0.001
b.
Evening dose:	Placebo	UMEC QD
12–24-hour		15.6 μg	31.25 μg	62.5 μg	125 μg
weighted mean FEV 1 (L)	N = 60	N = 60	N = 57	N = 59	N = 60
n	54	56	52	54	56
LS mean (SE)	1.298 (0.020)	1.410 (0.020)	1.410 (0.020)	1.433 (0.020)	1.470 (0.020)
LS mean change (SE)	−0.103 (0.020)	0.010 (0.020)	0.010 (0.020)	0.032 (0.020)	0.069 (0.020)
Difference from placebo	N/A	0.112	0.112	0.135	0.172
95% CI	N/A	(0.064, 0.160)	(0.063, 0.162)	(0.085, 0.184)	(0.123, 0.221)
p-value	N/A	<0.001	<0.001	<0.001	<0.001
Evening dose:	UMEC BID				Tiotropium QD
12–24-hour	15.6 μg		31.25 μg		18 μg
weighted mean FEV 1 (L)	N = 56		N = 58		N = 56
n	52		55		53
LS mean (SE)	1.440 (0.020)		1.450 (0.020)		1.437 (0.020)
LS mean change (SE)	0.039 (0.020)		0.050 (0.020)		0.036 (0.020)
Difference from placebo	0.141		0.152		0.138
95% CI	(0.092, 0.191)		(0.103, 0.201)		(0.090, 0.187)
p-value	<0.001		<0.001		<0.001