Skip to main content

Advertisement

Table 5 Pre-Dose FEV 1 (L) Data, ITT population and patient subgroups

From: Fluticasone propionate/salmeterol 250/50 μg versus salmeterol 50 μg after chronic obstructive pulmonary disease exacerbation

  FP/SAL 250/50 μg (N = 314) SAL 50 μg (N = 325) LS Mean Diff. (SE) 95% CI
ITT population
Baseline FEV1 n 313 325  
Mean (SE) 1.08 (0.027) 1.14 (0.026)
Endpoint FEV1 n 281 271
Mean (SE) 1.22 (0.034) 1.18 (0.031)
Change from baseline n 280 271 0.10 (0.028) (0.04, 0.16)
Mean (SE) 0.14 (0.021) 0.04 (0.019)
Baseline post-bronchodilator % predicted FEV1≥ 30% and no prior ICS use
Baseline FEV1 n 60 66  
Mean (SE) 1.28 (0.057) 1.26 (0.054)
Endpoint FEV1 n 57 59
Mean (SE) 1.52 (0.083) 1.39 (0.072)
Change from baseline n 57 59 0.13 (0.083) (−0.04, 0.29)
Mean (SE) 0.25 (0.064) 0.13 (0.051)
Baseline post-bronchodilator % predicted FEV1≥ 30% and prior ICS use
Baseline FEV1 n 180 193  
Mean (SE) 1.20 (0.033) 1.26 (0.031)
Endpoint FEV1 n 162 159
Mean (SE) 1.30 (0.039) 1.28 (0.036)
Change from baseline n 162 159 0.10 (0.036) (0.03, 0.17)
Mean (SE) 0.12 (0.027) 0.01 (0.025)
Baseline post-bronchodilator % predicted FEV1≥ 30% and concurrent tiotropium use
Baseline FEV1 n 88 95  
Mean (SE) 1.17 (0.044) 1.19 (0.041)
Endpoint FEV1 n 79 71
Mean (SE) 1.24 (0.055) 1.21 (0.052)
Change from baseline n 79 71 0.02 (0.053) (−0.09, 0.12)
Mean (SE) 0.07 (0.037) 0.06 (0.041)
Baseline post-bronchodilator % predicted FEV1≥ 30% and no concurrent tiotropium use
Baseline FEV1 n 152 164  
Mean (SE) 1.25 (0.037) 1.31 (0.034)
Endpoint FEV1 n 140 147
Mean (SE) 1.43 (0.047) 1.36 (0.042)
Change from baseline n 140 147 0.16 (0.044) (0.07, 0.25)
Mean (SE) 0.21 (0.035) 0.03 (0.027)
Baseline post-bronchodilator % predicted FEV1< 30%
Baseline FEV1 n 72 65  
Mean (SE) 0.64 (0.032) 0.63 (0.022)
Endpoint FEV1 n 60 53
Mean (SE) 0.72 (0.046) 0.65 (0.025)
Change from baseline n 60 53 0.06 (0.037) (−0.01, 0.14)
Mean (SE) 0.08 (0.023) 0.01 (0.028)
  1. LS mean difference, SE and CI are from an ANCOVA model with terms for treatment, country, randomization stratum and baseline value. LS mean diffs. are calculated as FP/SAL 250/50 μg–SAL 50 μg. ANCOVA = analysis of covariance; CI = confidence interval; FEV1= forced expiratory volume in 1 second; FP = fluticasone propionate; ICS = inhaled corticosteroid; ITT = intent-to-treat; LS = least squares; SAL = salmeterol; SE = standard error.