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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.