Table 1

Baseline characteristics of randomised patients

CharacteristicMontelukast + budesonide 800 μg/day (n=448)Budesonide 1600 μg/day (n=441)Total (n=889)
*Mean (SD) values.
ICS=inhaled corticosteroids; PEF=peak expiratory flow; FEV1=forced expiratory volume in 1 second.
Age (years)*43 (14)43 (14)43 (14)
Age range15–7415–7515–75
Sex (% female)596160
Race (%)
    White77.276.676.9
    Black0.40.90.7
    Asian5.44.54.9
    Other17.017.917.4
Prestudy ICS dose, actual (μg/day)*730 (238)746 (237)738 (238)
Prestudy fluticasone dose (μg/day)*543.8 (220.1) (n=112)578.0 (187.3) (n=108)
Prestudy beclomethasone dose (μg/day)*778.2 (257.4) (n=103)775.2 (215.6) (n=109)
Prestudy budesonide dose (μg/day)*785.2 (193.2) (n=247)807.3 (230.1) (n=234)
Prestudy triamcinolone dose (μg/day)600 (1)600 (1)
Prestudy flunisolide dose (μg/day)800 (1)1000 (1)
Age first treated for asthma (years)*26 (17)26 (18)26 (18)
Asthma duration (years)*18 (14)17 (15)17 (14)
Morning PEF (l/min)*385 (130)383 (133)384 (131)
Daily β agonist use (puffs/day)*2.7 (2.4)2.7 (2.2)2.7 (2.3)
Daytime symptoms (range 0–6)*2.2 (0.9)2.2 (0.9)2.2 (0.9)
FEV1 (l)*2.3 (0.7)2.2 (0.7)2.3 (0.7)
FEV1 (% predicted)*69.0 (13.3)68.3 (13.4)68.7 (13.4)
Nocturnal awakenings (median % of days)12.313.813.3
Quality of life score*4.7 (1.1)4.7 (1.1)4.7 (1.1)
Asthma affected work/school (%)49.746.448.0
Days missed from work/school due to asthma in previous year*22.7 (52.3)20.2 (46.0)21.5 (49.3)
Oral corticosteroid treatment in previous year (% of patients)39.543.441.4
Number of visits with healthcare provider due to worsening asthma in previous year (for patients with at least one visit)*4.9 (5.1)4.6 (5.4)4.8 (5.3)