Skip to main content

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 point

Placebo (N =143)

UMEC 31.25 mcg (N =139)

UMEC 62.5 mcg (N =139)

n

Weeks −2 and − 1 (BL)

143

138

139

mean (SD)

 

2.222 (0.805)

2.304 (0.718)

2.248 (0.662)

n

Weeks 1–4

141

135

138

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)

n

Weeks 5–8

139

128

135

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)

n

Weeks 9–12

135

130

132

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)

n

Weeks 13–16

128

124

125

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)

n

Weeks 17–20

126

123

124

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)

n

Weeks 21–24

128

123

125

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)

n

Weeks 1–24*

142

137

138

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