Table 1.

Baseline Characteristics of Study Participants

	Treatment Assignment*			P-value†
	F/S	F	M
Number of participants	64	65	60	0.46
Mean age at randomization (years; SD)	34.3(15.4)	31.5(14.9)	36.4(15.6)	0.20
Male (%)	33	38	38	0.77
Smokers (> 20 packs per lifetime, %)	38	11	22	0.001
Mean pack-years (years; SD)	5.7(5.2)	8.6(6.0)	5.8(4.3)	0.41
Asthma characteristics
Mean age at onset of asthma (years; SD)	17.6(18.7)	20.5(27.1)	17.8(19.2)	0.71
≥1 emergency visits for asthma in the previous year	38	26	27	0.27
≥1 course of oral corticosteroids in the previous year	33	21	25	0.31
Use of rescue inhaler >1 time per week (%)	59	70	68	0.41
On inhaled corticosteroids at baseline (%)	27	27	28	0.98
Asthma Control Scores (Mean±SD)‡
ACQ at enrollment	1.77(0.76)	1.74(0.73)	1.8(0.90)	0.87
ACQ at randomization	0.75(0.38)	0.70(0.34)	0.72(0.41)	0.71
ASUI at randomization	0.89(0.08)	0.88(0.09)	0.88(0.11)	0.72
Pulmonary Function (Pre-Bronchodilator, Mean±SD)§
Peak Flow at enrollment (L/min)	407(124)	382(111)	400(108)	0.45
Peak Flow at randomization (L/min)	412(109)	398(105)	422(109)	0.48
FVC at enrollment (L)	3.88(1.04)	3.74(1.11)	3.86(1.13)	0.72
FVC at randomization (L)	4.03(1.07)	3.94(1.09)	4.05(1.20)	0.83
FEV1 at enrollment (L)	2.82(0.79)	2.75(0.78)	2.80(0.75)	0.86
FEV1 at randomization (L)	3.01(0.80)	3.00(0.78)	3.05(0.79)	0.92
% Predicted FEV1 at enrollment||	84.1(12.0)	84.1(12.8)	83.2(11.2)	0.89
% Predicted FEV1 at randomization||	89.4(9.7)	91.7(8.9)	90.8(10.2)	0.38

^*F/S, combination of fluticasone and salmeterol ; F, fluticasone; M, montelukast

^†P-values were derived from a Pearson’s Χ² goodness-of-fit test for categorical variables and from ANOVA for continuous variables²¹.

^‡ACQ, Asthma Control Questionnaire; ASUI, Asthma Symptom Utility Index

^§FVC, forced vital capacity; FEV1, forced expiratory volume in 1 second

^||Predicted values for pulmonary function were calculated as described by Hankinson et al.¹⁷.