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Table 6 Change from baseline in weighted mean FEV 1 (L) difference in treatment effect compared between 12–24-hour and 0–12-hour at Day 7 (mITT population)

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

  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 54 58 53 56 56
Column vs. placebo N/A 0.018 −0.007 0.021 0.010
Absolute difference
95% CI N/A (−0.040, 0.076) (−0.067, 0.053) (−0.038, 0.080) (−0.048, 0.069)
Ratio* N/A 1.176 0.943 1.162 1.059
  UMEC BID Tiotropium QD
15.6 μg 31.25 μg 18 μg
N= 56 N= 58 N= 56
N 52 55 53
Column vs. placebo 0.019 0.028 −0.036
Absolute difference
95% CI (−0.041, 0.078) (−0.030, 0.087) (−0.095, 0.023)
Ratio* 1.147 1.215 0.793
  1. *Relative to 0–12-hour weighted mean FEV1.
  2. Absolute differences >0 indicate a larger treatment effect between 12–24 hours; analysis performed using a mixed model with covariates trough mean baseline, trough period baseline, treatment, period, time and time by treatment interaction as fixed effects and subject as a random effect.
  3. Note: The column versus placebo difference was calculated as the difference in change from baseline in weighted mean FEV1 between active and placebo at 12–24 hours minus the difference in change from baseline in weighted mean FEV1 between active and placebo at 0–12 hours. The ratio is the difference in change from baseline in weighted mean FEV1 between active and placebo at 12–24 hours divided by the difference in change from baseline in weighted mean FEV1 between active and placebo at 0–12 hours.
  4. BID, twice daily; CI, confidence interval; N/A, not applicable; QD, once daily; UMEC, umeclidinium bromide.