Table 2.
Lung function measures | Placebo | VI 6.25 μg | VI 12.5 μg | VI 25 μg | Total |
---|---|---|---|---|---|
N = 115 | N = 114 | N = 113 | N = 114 | N = 456 | |
Screening | |||||
Pre-bronchodilator PEF (L/min) | |||||
n | 115 | 114 | 113 | 114 | 456 |
Mean | 185.05 | 178.35 | 179.22 | 177.09 | 179.94 |
SD | 59.30 | 55.67 | 60.57 | 55.68 | 57.74 |
Post-bronchodilator PEF (L/min) | |||||
n | 115 | 114 | 113 | 114 | 456 |
Mean | 238.79 | 232.29 | 234.54 | 228.37 | 233.51 |
SD | 67.41 | 69.80 | 69.79 | 72.29 | 69.71 |
Percentage of pre- to post-bronchodilator PEF (%) | |||||
n | 115 | 114 | 113 | 114 | 456 |
Mean | 76.95 | 76.86 | 75.87 | 78.02 | 76.93 |
SD | 9.18 | 9.57 | 10.90 | 8.17 | 9.50 |
Pre-bronchodilator FEV1 (L) | |||||
n | 91 | 91 | 97 | 102 | 381 |
Mean | 1.405 | 1.370 | 1.374 | 1.361 | 1.377 |
SD | 0.408 | 0.423 | 0.445 | 0.429 | 0.426 |
Post-bronchodilator FEV1 (L) | |||||
n | 99 | 98 | 96 | 103 | 396 |
Mean | 1.700 | 1.702 | 1.699 | 1.680 | 1.695 |
SD | 0.457 | 0.532 | 0.465 | 0.496 | 0.487 |
Pre-bronchodilator FEV1 (% predicted)a | |||||
n | 91 | 91 | 97 | 102 | 381 |
Mean | 86.83 | 82.92 | 85.04 | 84.08 | 84.70 |
SD | 19.83 | 17.00 | 17.34 | 16.77 | 17.73 |
Post-bronchodilator FEV1 (% predicted)a | |||||
n | 99 | 98 | 96 | 103 | 396 |
Mean | 106.81 | 101.10 | 104.34 | 104.58 | 104.22 |
SD | 20.94 | 18.47 | 16.68 | 19.97 | 19.15 |
Baseline | |||||
Pre-bronchodilator PEF (L/min) | |||||
n | 115 | 114 | 113 | 114 | 456 |
Mean | 186.27 | 185.08 | 181.24 | 179.39 | 183.00 |
SD | 60.64 | 59.17 | 55.19 | 56.82 | 57.88 |
Percentage of pre- to post-bronchodilator PEF (%) | |||||
n | 115 | 114 | 113 | 114 | 456 |
Mean | 77.77 | 79.54 | 77.58 | 79.13 | 78.51 |
SD | 10.49 | 9.09 | 10.11 | 9.77 | 9.88 |
Pre-bronchodilator FEV1 (L)b | |||||
n | 96 | 91 | 97 | 103 | 387 |
Mean | 1.367 | 1.408 | 1.361 | 1.365 | 1.374 |
SD | 0.421 | 0.454 | 0.398 | 0.398 | 0.416 |
Pre-bronchodilator FEV1 (% predicted)a,b | |||||
n | 96 | 91 | 97 | 103 | 387 |
Mean | 84.37 | 83.99 | 85.43 | 85.75 | 84.91 |
SD | 19.35 | 16.99 | 17.66 | 18.38 | 18.08 |
FEV 1 forced expiratory volume in one second, ITT intention-to-treat, PEF peak expiratory flow, SD standard deviation, VI vilanterol
a% predicted FEV1 data are posthoc analyses
bThree children had post-dose FEV1 at baseline and were not included in any FEV1 secondary endpoint analyses