Table 1.

Baseline Characteristics of the Patients

CharacteristicPlacebo

(n = 228)
Montelukast (4 mg)
(n = 461)
Age (y)3.6 ± 1.13.6 ± 1.1
 Range* 2–6 2–6
Male sex (%)58 59
Race (%)
 White57 56
 Hispanic20 21
 Black 9 8
 Other 14 15
Weight (kg)17.5 ± 4.117.6 ± 4.3
Height (cm)103 ± 9102 ± 10
Duration of asthma (y)2.4 ± 1.32.4 ± 1.3
 Range0.5–60.5–6
History of activity-induced asthma (%)81 77
Concomitant inhaled corticosteroid (%)29 27
Concomitant cromolyn (%)11 14
Abnormal RAST(%)51 47
Asthma symptoms (days/wk) 6.1 6.2
β-agonist use (days/wk) 5.6 5.6
  • * Nine patients were 6 years old at randomization: 8 patients turned 6 between prestudy and randomization visits; and one 6-year-old's age was erroneously reported as 5 years at the prestudy visit.

  • Other includes American and Canadian Indian, Arabic, Asian, mestizo, and other races.

  • Normal values, ≤11 IU/mL at 1 to 2 years of age, ≤23 IU/mL at 3 years, and ≤49 IU/mL at 4 to 5 years.

    Plus-minus values are means ± standard deviation.