Table 1
Baseline characteristics of randomised patients
| Characteristic | Montelukast + 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 range | 15–74 | 15–75 | 15–75 |
| Sex (% female) | 59 | 61 | 60 |
| Race (%) | |||
| White | 77.2 | 76.6 | 76.9 |
| Black | 0.4 | 0.9 | 0.7 |
| Asian | 5.4 | 4.5 | 4.9 |
| Other | 17.0 | 17.9 | 17.4 |
| 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) | 12.3 | 13.8 | 13.3 |
| Quality of life score* | 4.7 (1.1) | 4.7 (1.1) | 4.7 (1.1) |
| Asthma affected work/school (%) | 49.7 | 46.4 | 48.0 |
| 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) | 39.5 | 43.4 | 41.4 |
| 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) |
