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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)

From: Dose response of umeclidinium administered once or twice daily in patients with COPD: a randomised cross-over study

a.
Morning dose:   UMEC QD
0–12-hour Placebo 15.6 μg 31.25 μg 62.5 μg 125 μg
weighted mean FEV1(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