TABLE I.
Baseline characteristics
| Characteristic | Current study (ancillary adherence study) | Other CAMP participants (n = 379) | P value† | |||
|---|---|---|---|---|---|---|
| Budesonide (n = 84) | Placebo (n = 56) | P value* | Combined group (n = 140) | |||
| Demographics | ||||||
| Age (y) | 8.9 ± 2.0 | 8.9 ± 2.2 | .86 | 8.9 ± 2.0 | 9.1 ± 2.1 | .36 |
| Race/ethnic group, no. (%) | .75 | .049 | ||||
| Non-Hispanic white | 63 (75.0) | 39 (69.6) | 102 (72.9) | 249 (65.7) | ||
| Non-Hispanic black | 11 (13.1) | 11 (19.6) | 22 (15.7) | 48 (12.7) | ||
| Hispanic | 6 (7.1) | 3 (5.4) | 9 (6.4) | 37 (9.8) | ||
| Other | 4 (4.8) | 3 (5.4) | 7 (5.0) | 45 (11.9) | ||
| Sex, no. (%) | .73 | .32 | ||||
| Female | 38 (45.2) | 27 (48.2) | 65 (46.4) | 157 (41.4) | ||
| Male | 46 (54.8) | 29 (51.8) | 75 (53.6) | 222 (58.6) | ||
| Clinical measures based on patients’ report | ||||||
| Age at onset of asthma (y) | 3.1 ± 2.2 | 2.6 ± 2.4 | .28 | 2.9 ± 2.3 | 3.1 ± 2.4 | .32 |
| Years since asthma diagnosis | 5.3 ± 2.6 | 5.0 ± 2.9 | .43 | 5.1 ± 2.8 | 5.1 ± 2.6 | .96 |
| Severity of asthma, no. (%) | .73 | .11 | ||||
| Mild | 46 (54.8) | 29 (51.8) | 75 (53.6) | 173 (45.7) | ||
| Moderate | 38 (45.2) | 27 (48.2) | 65 (46.4) | 206 (54.4) | ||
| Ever hospitalized for asthma, no. (%) | 21 (25) | 16 (29) | .70 | 37 (26) | 128 (34) | .14 |
| Days of oral steroids in past 6 mo, median (range) | 0 (0–21) | 0 (0–18) | .52 | 0 (0–21) | 0 (0–42) | .95 |
| Diary card measures | ||||||
| Symptom score, median (range) | 0.4 (0–1) | 0.4 (0–1) | .79 | 0.4 (0–1) | 0.5 (0–1) | .01 |
| Asthma episode-free days (no./mo), median (range) | 8.3 (0–21.7) | 7.6 (0–30.4) | .86 | 7.7 (0–30.4) | 9.8 (0–29.3) | .50 |
| Use of albuterol for symptoms (puffs/wk), median (range) | 7.9 (0–42.5) | 8 (0–42) | .94 | 8 (0–42.5) | 7.5 (0–51.5) | .79 |
| Nighttime awakenings (no./mo), median (range) | 0 (0–4.3) | 0 (0–5.4) | .56 | 0 (0–5.4) | 0 (0–7.6) | .30 |
| Pulmonary function | ||||||
| Spirometric values before bronchodilator | ||||||
| FEV1, % predicted | 93.4 ± 14.0 | 92.4 ± 16.0 | .69 | 93.0 ± 14.8 | 93.8 ± 14.3 | .60 |
| Spirometric values after bronchodilator | ||||||
| FEV1 (% predicted) | 102.3 ± 13.8 | 102.2 ± 12.8 | .97 | 102.3 ± 13.4 | 103.5 ± 12.7 | .33 |
| FEV1 (L) | 1.8 ± 0.5 | 1.7 ± 0.5 | .33 | 1.8 ± 0.5 | 1.8 ± 0.5 | .18 |
| FVC after bronchodilator (L) | 2.1 ± 0.7 | 2.0 ± 0.6 | .34 | 2.1 ± 0.6 | 2.2 ± 0.6 | .18 |
| FEV1/FVC ratio (%) | 85.3 ± 6.2 | 85.3 ± 6.6 | .96 | 85.3 ± 6.3 | 85.3 ± 6.7 | .98 |
| Airway responsiveness to methacholine (PC20; mg/mL), geometric mean (95% CI) | 1.0 (0.8–1.3) | 1.0 (0.7–1.4) | >.99 | 1.0 (0.8–1.2) | 1.1 (1.0–1.3) | .43 |
| Height and bone density | ||||||
| Height (cm) | 134.0 ± 14.2 | 132.0 ± 13.4 | .41 | 133.2 ± 13.9 | 134.3 ± 13.0 | .43 |
| Height (percentile) | 58.7 ± 27.0 | 47.4 ± 30.6 | .03 | 54.3 ± 28.9 | 56.2 ± 28.5 | .50 |
| Bone mineral density (g/cm2) | 0.66 ± 0.12 | 0.67 ± 0.11 | .77 | 0.66 ± 0.12 | 0.65 ± 0.10 | .07 |
Numbers represent means ± SDs, unless otherwise noted.
*
P value for comparison of the budesonide and budesonide placebo groups in the current study.
†
P value for comparison of the combined group in the current study versus other CAMP participants randomized to budesonide or budesonide placebo in all 8 clinical sites.