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Table 4 Trough 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

Trough FEV1(L) Placebo UMEC QD
15.6 μg 31.25 μg 62.5 μg 125 μg
N = 60 N = 60 N = 57 N = 59 N = 60
N 60 59 56 59 60
LS mean (SE) 1.401 (0.019) 1.469 (0.019) 1.482 (0.020) 1.475 (0.019) 1.521 (0.019)
LS mean change (SE) −0.014 (0.019) 0.054 (0.019) 0.067 (0.020) 0.060 (0.019) 0.106 (0.019)
Difference from placebo N/A 0.068 0.081 0.074 0.120
95% CI N/A (0.018, 0.118) (0.030, 0.131) (0.024, 0.124) (0.070, 0.170)
p-value N/A 0.007 0.002 0.004 <0.001
Trough FEV 1 (L) UMEC BID Tiotropium QD
15.6 μg 31.25 μg 18 μg
N= 56 N= 58 N= 56
N 55 57 56
LS mean (SE) 1.484 (0.020) 1.500 (0.020) 1.493 (0.020)
LS mean change (SE) 0.069 (0.020) 0.085 (0.020) 0.078 (0.020)
Difference from placebo 0.083 0.099 0.092
95% CI (0.032, 0.134) (0.048, 0.149) (0.041, 0.142)
p-value 0.001 <0.001 <0.001
  1. Analysis performed using a mixed model with covariates of period baseline, mean baseline, treatment and period as fixed effects and patient as a random effect; for each treatment period, baseline was defined as the mean of the values obtained 5 and 30 minutes pre-dose on Day 1 and trough FEV1 is calculated from the FEV1 values obtained 23 and 24 hours after the Day 6 morning dose.
  2. BID, twice daily; CI, confidence interval; FEV1, forced expiratory volume in 1 second; LS, least square; mITT, modified intent-to-treat; N/A, not applicable; QD, once daily; SE, standard error; UMEC, umeclidinium bromide.