Table 2.
Outcomes at 1 Year.*
| Outcome | Intermittent Regimen (N = 139) | Daily Regimen (N = 139) | Treatment Effect† |
|---|---|---|---|
| Event Rate/Person-Yr (95% CI) | Relative Rate (95% CI) | ||
|
| |||
| No. of prednisolone courses for asthma‡ | 0.95 (0.75 to 1.20) | 0.97 (0.76 to 1.22) | 0.99 (0.71 to 1.35) |
|
| |||
| No. of treatments for respiratory tract illness‡ | 3.61 (3.13 to 4.16) | 3.27 (2.82 to 3.79) | 1.10 (0.91 to 1.35) |
|
| |||
| No. of urgent care visits for asthma‡ | 2.37 (1.89 to 2.97) | 2.40 (1.91 to 3.02) | 0.99 (0.72 to 1.35) |
|
| |||
| No. of days absent from work, school, or day care‡ | 2.72 (2.00 to 3.70) | 3.02 (2.22 to 4.12) | 0.90 (0.59 to 1.37) |
| Proportion (95% CI) | Relative Proportion (95% CI) | ||
| Respiratory tract illnesses in which prednisolone was administered‡ | 0.24 (0.19 to 0.29) | 0.26 (0.21 to 0.32) | 0.90 (0.68 to 1.19) |
|
| |||
| Respiratory tract illnesses with virus detected in nasal sample | 0.83 (0.74 to 0.92) | 0.83 (0.74 to 0.93) | 1.00 (0.85 to 1.17) |
|
| |||
| Respiratory tract illnesses with exacerbations and nasal virus detected | 0.79 (0.61 to 1.02) | 0.78 (0.61 to 1.01) | 1.00 (0.70 to 1.44) |
| Mean Value (95% CI) | Mean Difference (95% CI) | ||
| Episode-free days — % | 78 (75 to 80) | 78 (76 to 81) | −0.7 (−4.0 to 2.0) |
|
| |||
| Episode-free days, excluding days during treatment for respiratory tract illness — % | 85 (82 to 87) | 84 (82 to 86) | 0.5 (−3.0 to 4.0) |
|
| |||
| Days with albuterol use — % | 6 (5 to 7) | 5 (4 to 6) | 0.4 (−1.0 to 2.0) |
|
| |||
| Annualized days of treatment with budesonide — no. | 24 (21 to 27) | 337 (330 to 344) | −314 (−322 to −306) |
|
| |||
| Cumulative dose of budesonide — mg | 46 (39 to 53) | 150 (140 to 160) | −104 (−116 to −92) |
|
| |||
| Change in height from baseline | |||
|
| |||
| Value — cm | 8.01 (7.71 to 8.30) | 7.76 (7.45 to 8.07) | 0.26 (−0.17 to 0.68) |
|
| |||
| Percentile | 4.04 (2.07 to 6.00) | 2.39 (0.14 to 4.64) | 1.65 (−1.34 to 4.63) |
|
| |||
| z score | 0.12 (0.04 to 0.20) | 0.10 (0.02 to 0.18) | 0.02 (−0.10 to 0.13) |
|
| |||
| Change in weight from baseline | |||
|
| |||
| Value — kg | 2.54 (2.37 to 2.71) | 2.38 (2.20 to 2.55) | 0.16 (−0.08 to 0.41) |
|
| |||
| Percentile | 4.11 (2.07 to 6.16) | 0.73 (−1.39 to 2.85) | 3.38 (0.43 to 6.33) |
|
| |||
| z score | 0.15 (0.07 to 0.22) | 0.05 (−0.03 to 0.13) | 0.10 (−0.01 to 0.21) |
|
| |||
| Change in head circumference from baseline | |||
|
| |||
| Value — cm | 0.92 (0.79 to 1.05) | 0.87 (0.74 to 1.00) | 0.05 (−0.14 to 0.23) |
|
| |||
| Percentile | −1.20 (−3.45 to 1.04) | −3.59 (−6.67 to −0.51) | 2.39 (−1.43 to 6.20) |
|
| |||
| z score | −0.07 (−0.17 to 0.03) | −0.13 (−0.24 to −0.02) | 0.06 (−0.09 to 0.21) |
|
| |||
| Days with diary-card adherence — % | 83 (78 to 88) | 88 (84 to 92) | −5 (−11 to 2) |
|
| |||
| Days with adherence to budesonide or placebo — %§ | |||
|
| |||
| Daily | 94 (93 to 96) | 95 (94 to 96) | −1 (−2 to 1) |
|
| |||
| During respiratory tract illness | 81 (75 to 87) | 82 (75 to 89) | −1 (−10 to 8) |
*
All outcomes have been adjusted for age and clinical center. Growth was measured in 113 children in the intermittent-regimen group and 110 in the daily-regimen group. All other outcomes included data from the entire cohort.
†
The treatment effect was calculated as the value in the intermittent-regimen group divided by the value in the daily-regimen group.
‡
Models were also adjusted for sex, race, and atopy, since results were similar with adjustment for age and clinical center only.
§
Treatment adherence was evaluated on days for which diary data were available.