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Table 2 Effect of UMEC 31.25 and 62.5 mcg versus placebo on home trough FEV1

From: A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids

 Time pointPlacebo (N =143)UMEC 31.25 mcg (N =139)UMEC 62.5 mcg (N =139)
nWeeks −2 and − 1 (BL)143138139
mean (SD) 2.222 (0.805)2.304 (0.718)2.248 (0.662)
nWeeks 1–4141135138
LS mean change (SE) −0.034 (0.023)0.029 (0.023)0.046 (0.023)
Difference vs placebo (95% CI)  0.064 (0.000, 0.127)0.080 (0.017, 0.144)
nWeeks 5–8139128135
LS mean change (SE) − 0.046 (0.027)0.018 (0.027)0.063 (0.027)
Difference vs placebo (95% CI)  0.064 (−0.011, 0.139)0.109 (0.034, 0.184)
nWeeks 9–12135130132
LS mean change (SE) −0.058 (0.027)0.045 (0.027)0.054 (0.027)
Difference vs placebo (95% CI)  0.103 (0.028, 0.178)0.112 (0.037, 0.186)
nWeeks 13–16128124125
LS mean change (SE) −0.026 (0.028)0.052 (0.028)0.058 (0.028)
Difference vs placebo (95% CI)  0.079 (0.000, 0.157)0.084 (0.006, 0.162)
nWeeks 17–20126123124
LS mean change (SE) −0.023 (0.029)0.039 (0.029)0.065 (0.029)
Difference vs placebo (95% CI)  0.061 (−0.019, 0.142)0.087 (0.007, 0.167)
nWeeks 21–24128123125
LS mean change (SE) −0.038 (0.029)0.033 (0.030)0.081 (0.029)
Difference vs placebo (95% CI)  0.071 (−0.011, 0.152)0.118 (0.037, 0.199)
nWeeks 1–24*142137138
LS mean change (SE) −0.038 (0.024)0.036 (0.025)0.061 (0.024)
Difference vs placebo (95% CI)  0.074 (0.006, 0.141)0.098 (0.031, 0.166)
  1. *Treatment effect averaged over all time points. These analyses were performed using an MMRM model with covariates of treatment, age, sex, region, baseline value and 4-weekly period, and with interaction terms for baseline by period and treatment by period.
  2. BL baseline, CI confidence interval, FEV1 forced expiratory volume in 1 s, LS least squares, MMRM mixed model repeated measures, SD standard deviation, SE standard error, UMEC umeclidinium