Table 2.
Change in primary and secondary forced expiratory volume in 1 second (FEV1) endpoints between days 0 and 84 of randomized therapy (per-protocol set).
|
Parameter
|
Change (L)
|
Treatment difference*
|
||||
|---|---|---|---|---|---|---|
| Treatment | N | LS mean | 95% CI | LS mean | 95% CI | p value$ |
| Change in predose FEV1 from day 0 to day 84 (l) | ||||||
| FP/FORM | 102 | 0.182 | 0.127, 0.236 | −0.031 | −0.093, 0.031 | 0.026 |
| FP/SAL | 99 | 0.212 | 0.160, 0.265 | – | – | – |
| Change in FEV1 from day 0 (predose) to day 84 (2-hours postdose; l) | ||||||
| FP/FORM | 102 | 0.308 | 0.243, 0.373 | −0.017 | −0.089, 0.055 | 0.025 |
| FP/SAL | 99 | 0.325 | 0.263, 0.387 | – | – | – |
CI, confidence interval; FEV1, forced expiratory volume in 1 second; FP/FORM, fluticasone propionate/formoterol fumarate; FP/SAL, fluticasone propionate/salmeterol xinafoate; LS mean, least squares mean from ANCOVA with treatment and age group as factors, predose FEV1 value at day 0 as a covariate and center as a random effect.
*
Difference between FP/FORM and FP/SAL; $p value for noninferiority [shown if the lower limit of the 95% CI (95.35% CI for change in predose FEV1) from ANCOVA was ⩾ –0.1 l].