Table 1.
Participant Characteristics
| Montelukast (N=95) |
Budesonide (N=96) |
Conventional Therapy (N=47) |
|
|---|---|---|---|
| Demographics/Asthma History | |||
| Age (months) | 35.4 ± 12.4 | 36.7 ± 13.5 | 35.7 ± 13.7 |
| Male (%) * | 65.3 | 72.9 | 48.9 |
| Minority (%) | 23.2 | 25.0 | 25.5 |
| Height (cm) | 95.2 ± 8.0 | 95.2 ± 9.6 | 94.4 ± 10.2 |
| Age at MD diagnosis of asthma (yrs)** |
1.4 ± 0.9 (N=56) | 1.6 ± 1.1 (N=62) | 1.5 ± 1.1 (N=31) |
| Age of onset of asthma (yrs)** | 1.0 ± 0.8 (N=56) | 1.1 ± 1.0 (N=62) | 1.0 ± 0.9 (N=30) |
| ED visits for wheezing in past year | |||
| Number per year | 1.1 ± 2.9 | 0.9 ± 1.4 | 1.1 ± 1.5 |
| Percentage of participants | 36.8 | 40.6 | 46.8 |
| MD visits for wheezing in past year |
|||
| Number per year | 4.3 ± 3.4 | 3.7 ± 2.5 | 4.7 ± 3.4 |
| Percentage of participants | 9.5 | 5.2 | 10.6 |
| Missed school/daycare days in past year |
5.5 ± 12.4 (N=58) |
4.8 ± 6.2 (N=65) | 3.7 ± 5.6 (N=34) |
| Exposed to tobacco smoke at home or daycare (%) |
4.2 | 4.2 | 1.7 |
| Medication use in previous year | |||
| Any controller(%) | 36.8 | 36.5 | 27.7 |
| Inhaled corticosteroid (%) | 34.7 | 32.3 | 19.2 |
| Leukotriene modifier (%) | 6.3 | 7.3 | 8.5 |
| Long-acting β-agonist (%) | 1.1 | 0 | 0 |
| Number of oral corticosteroid courses n (%) |
0 = 35 (36.8%) 1 = 25 (26.3%) 2 = 17(17.9%) 3 = 6 (6.3%) 4+ = 12 (12.6%) |
0 = 39 (40.6%) 1 = 21 (21.9%) 2 = 25 (26.0%) 3 = 8 (8.3%) 4+ = 3 (3.1%) |
0 = 22 (46.8%) 1 = 13 (27.7%) 2 = 8 (17.0%) 3 = 2 (4.3%) 4+ = 2 (4.3%) |
| Atopic characteristics | |||
| Positive aeroallergen ST (%) | 50.0 | 44.8 | 44.7 |
| Positive aeroallergen ST (#) | 1.0 ± 1.3 | 0.8 ± 1.3 | 0.8 ± 1.1 |
| IgE (IU/mL) — Geo Mean ± CV | 35.4 ± 5.5 | 39.8 ± 4.5 | 47.5 ± 6.0 |
| Eosinophils (%) | 4.0 ± 2.7 | 4.4 ± 3.0 | 4.6 ± 3.4 |
| Eczema (%) | 28.4 | 34.4 | 42.6 |
| Parental asthma (%) | 43.6 | 41.7 | 53.2 |
| API Positive (%) | 60.0 | 58.3 | 66.0 |
| Quality of Life | |||
| PACQLQ overall score † | 6.6 ± 0.6 | 6.5 ± 0.9 | 6.5 ± 0.8 |
| PedsQL total scale score ‡ | 89.8 ± 8.8 | 88.3 ± 12.6 | 90.6 ± 7.9 |
Data are expressed as mean ± SD except at noted.
*
p=0.019 across treatment groups.
†
Highest possible score = 7
‡
Highest possible score = 100
**
Among those participants with an asthma diagnosis (number of participants noted in parentheses).
Differences not significant for characteristic across treatment groups except as noted.