Table 1 Total nasal symptom score (TNSS) primary and secondary efficacy endpoints

Primary endpoint: absolute change from baseline to day 8 in TNSS AUC(0–1)

  Pretreatment mean (SD)

5.660 (1.206)

5.708 (1.436)

0.0003

    Day 8 mean (SD)

4.155 (1.889)

2.395 (2.034)

    Change from baseline LS mean (SE)

−1.523 (0.326)

−3.394 (0.335)

    LS mean difference vs placebo (SE)

−1.771 (0.468)

    95% CI

(−2.704, −0.838)

Secondary endpoints: percent change from baseline to day 8, 29, 57, and 85 in TNSS AUC(0–1)

% change from baseline to day 8 LS mean (SE)

−26.156 (5.635)

−55.503 (5.798)

0.0005

    LS mean difference vs placebo (SE)

−29.347 (8.086)

    95% CI

(−45.486, −13.208)

% change from baseline to day 29 LS mean (SE)

−27.886 (6.36)

−61. 175 (6.360)

0.0004

    LS mean difference vs placebo (SE)

−33.289 (8.995)

    95% CI

(−51.253, −15.325)

% change from baseline to day 57 LS mean (SE)

−36.617 (6.678)

−51.141 (6.781)

0.1321

    LS mean difference vs placebo (SE)

−14.524 (9.519)

    95% CI

(−33.551, 4.504)

% change from baseline to day 85 LS mean (SE)

−27.851 (6.877)

−51.344 (6.877)

0.0187

    LS mean difference vs placebo (SE)

−23.492 (9.729)

    95% CI

(−42.935, −4.050)