Table 4.

Weighted Sum of the Change From Baseline in NCSi Scores From Hours 1 to 4 and Hours 6 to 8 on Day 1 (Secondary End Points, Efficacy Analysis Set, N = 563)

	Pseudoephedrine (N = 284)		Placebo (N = 279)
Day 1	Actual Result	Weighted Sum of Change From Baseline	Actual Result	Weighted Sum of Change From Baseline
Baseline
Mean (SD)	3.3 (0.47)		3.3 (0.47)
Median	3.0		3.0
Min, max	3, 4		3, 4
Sum of hours 1‐4
Mean (SD)		5.5 (3.48)		4.9 (3.60)
Median		6.0		5.0
Min, max		−2, 16		−3, 16
LS mean (SE)		5.9 (0.21)		5.3 (0.21)
Study drug difference
LS mean difference (SE)		0.6 (0.29)
95%CI		(0.08‐1.21)
P value		.026
Sum of hours 6‐8
Mean (SD)		6.4 (3.77)		5.8 (4.02)
Median		6.0		6.0
Min, max		–2, 16		–4, 16
LS mean (SE)		6.7 (0.23)		6.2 (0.23)
Study drug difference
LS mean difference (SE)		0.5 (0.32)
95%CI		(–0.09 to 1.16)
P value		.091

CI, confidence interval; LS, least squares; max, maximum; min, minimum; NCSi, Nasal Congestion Severity (instantaneous); SD, standard deviation; SE, standard error.

The NCSi score was based on a scale ranging from 0 (not stuffy at all) to 4 (very stuffy). The weights used were equal to the elapsed time in hours since the previous time point.

Baseline was defined as the last available assessment before the first dose of study drug. The change from baseline was calculated as baseline minus postbaseline. Positive differences between study drug groups indicated a greater effect for pseudoephedrine relative to placebo.

P values were based on an analysis of variance for each time interval with baseline congestion severity, age category, and treatment as factors.