Table 2.
Study Outcomes
| Montelukast (N=94) |
Budesonide (N=96) |
Conventional Therapy (N=47) |
|
|---|---|---|---|
| Primary Outcome | |||
| Proportion of episode free days* |
0.73 (0.66, 0.79) | 0.76 (0.70, 0.81) | 0.74 (0.65, 0.81) |
| Secondary Outcomes | |||
| Number of RTIs/participant |
3.4 (2.9, 3.9) | 3.7 (3.2, 4.2) | 3.6 (3.0, 4.3) |
| Oral corticosteroid use | |||
| Time to first oral corticosteroid course (days) (Median; Lower quartile, upper quartile) |
292 (85, 364) | 354 (137, 365) | 292 (127, 359) |
| Number of oral corticosteroid courses/participant* |
1.0 (0.7, 1.3) | 0.7 (0.5, 1.0) | 0.9 (0.6, 1.4) |
| % of participants receiving ≥1 course |
46.8 (36.4, 57.4) | 38.5 (28.8, 49.0) | 55.3 (40.1, 69.8) |
| Days of oral corticosteroid use/participant* |
4.3 (3.7, 5.8) | 2.9 (2.1, 4.1) | 3.0 (1.9, 4.8) |
| Health care utilization | |||
| % with at least 1 urgent care or ED visit |
54.8 (44.7, 65.6) | 53.7 (43.7, 64.4) | 55.6 (40.1, 69.8) |
| Hospitalization (%) | 6.4 (2.4, 13.4) | 2.1 (0.25, 7.3) | 8.5 (2.4, 20.4) |
| Number of urgent care and ED visits/participant* |
1.5 (1.1, 2.0) | 1.1 (0.8, 1.5) | 1.6 (1.1, 2.3) |
| Days missed from school or daycare/participant (# who attended school or daycare)* |
2.9 (2.0, 4.3) (N=61) |
2.1 (1.4, 3.1) (N=69) |
2.6 (1.7, 4.1) (N=35) |
| Quality of Life | |||
| PACQLQ total score (change)* † |
−0.11 (−0.33, 0.11) | −0.04 (−0.24, 0.17) | −0.03 (−0.25, 0.31) |
| PedsQL total scale score (change)* † |
0.88 (−2.31, 4.08) | 0.49 (−3.07, 4.04) | −2.79 (−7.02, 1.45) |
| Growth (cm) | 7.9 (7.4, 8.3) | 7.8 (7.4, 8.1) | 7.5 (7.0, 8.1) |
Data are expressed as mean (95% CI) except at noted.
Differences not significant for characteristic across treatment groups.
*
Values adjusted for age group (12-23 mos, 24-59 mos), asthma predictive index status (positive, negative), and clinical center
†
Increases in PACQLQ total score and PedsQL total scale score indicate improvements in quality of life