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Table 3 0–24-hour weighted mean FEV 1 (L) on Day 7 (mITT population)

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

0–24-hour weighted mean FEV1(L) Placebo N = 60 UMEC QD
15.6 μg 31.25 μg 62.5 μg 125 μg
N = 60 N = 57 N = 59 N = 60
N 54 56 51 54 56
LS mean (SE) 1.327 (0.018) 1.443 (0.018) 1.445 (0.019) 1.459 (0.018) 1.500 (0.018)
LS mean change (SE) −0.074 (0.018) 0.043 (0.018) 0.045 (0.019) 0.059 (0.018) 0.100 (0.018)
Difference from placebo NA 0.116 0.118 0.132 0.173
95% CI NA (0.072, 0.160) (0.073, 0.163) (0.087, 0.178) (0.129, 0.217)
p-value NA <0.001 <0.001 <0.001 <0.001
0–24-hour UMEC BID Tiotropium
weighted mean FEV 1 (L) 15.6 μg 31.25 μg QD 18 μg
N= 56 N= 58 N= 56
N 52 55 53
LS mean (SE) 1.462 (0.018) 1.469 (0.018) 1.484 (0.018)
LS mean change (SE) 0.062 (0.018) 0.068 (0.018) 0.084 (0.018)
Difference from placebo 0.136 0.142 0.157
95% CI (0.091, 0.181) (0.098, 0.186) (0.113, 0.202)
p-value <0.001 <0.001 <0.001
  1. Note: Analysis performed using a mixed model with covariates of trough mean baseline, trough period baseline, treatment and period as fixed effects and subject as a random effect.
  2. For each treatment period, baseline was defined as the mean of the values obtained 5 and 30 minutes predose on Day 1.
  3. BID, twice daily; CI, confidence interval; FEV1, forced expiratory volume in 1 second; LS, least square; mITT, modified intent-to-treat; NA, not applicable; QD, once daily; SE, standard error; UMEC, umeclidinium bromide.