Table I.
Characteristics of study participants at randomization
| Non-overweight | Overweight/obese | |||||
|---|---|---|---|---|---|---|
| Budesonide | Placebo/nedocromil | All | Budesonide | Placebo/nedocromil | All | |
| N | 205 | 500 | 705 | 103 | 219 | 322 |
| Age (yrs) | 9.0 (2.04) | 8.7 (2.12) | 8.8 (2.10)* | 9.1 (2.11) | 9.3 (2.12) | 9.2 (2.11) |
| Duration of asthma (yrs) | 5.9 (2.5) | 5.7 (2.6) | 5.8 (2.6)* | 6.1 (2.6) | 6.2 (2.7) | 6.1 (2.7) |
| Male gender | 59% | 61% | 60% | 58% | 59% | 59% |
| Race: White | 70% | 73% | 72%* | 55% | 62% | 60% |
| African-American | 11% | 11% | 11%* | 20% | 17% | 18% |
| Hispanic/Other | 19% | 16% | 17% | 24% | 21% | 22% |
| Tobacco exposure | 38% | 35% | 36% | 36% | 43% | 41% |
| BMI (percentile) | 50.4 (22.8) | 48.8 (23.7) | 49.3 (23.5)* | 93.9 (4.1) | 93.5 (4.3) | 93.6 (4.2) |
| BMI (absolute) | 16.5 (1.5) | 16.3 (1.6) | 16.4 (1.6)* | 22.2 (3.7) | 22.1 (3.3) | 22.1 (3.4) |
| Height (cm) | 132.5 (12.8) | 131.2 (13.5) | 131.5 (13.3)* | 137.3 (14.4) | 138.1 (13.6) | 137.8 (13.8) |
| Pre FEV1 (%pred) | 93.2 (14.7) | 93.7 (13.9) | 93.6 (14.1) | 94.2 (13.8) | 93.9 (15.0) | 94.0 (14.6) |
| Pre FEV1/FVC (%) | 79.9 (8.8) | 80.0 (8.3) | 80.0 (8.4)* | 78.3 (7.7) | 79.1 (8.3) | 78.9 (8.1) |
| BDR (FEV1 % change) | 11.9 (11.4) | 10.8 (10.0) | 11.1 (10.4) | 9.8 (9.2) | 10.1 (10.1) | 10.0 (9.8) |
| Vitamin D (log10) | 1.58 (.17)† | 1.54 (.19) | 1.55 (.18)* | 1.55 (.19)† | 1.49 (.19) | 1.51 (.19) |
| Total IgE (IU/mL)1 | 398 (145–1072) | 452 (186–1259) | 427 (178–1175) | 490 (191–1047) | 468 (162–1445) | 468 (174–1259) |
| Eosinophils (cell/mm3)1 | 398 (200–653) | 407 (200–646) | 398 (200–647) | 339 (180–543) | 390 (200–676) | 355 (200–617) |
| Compliance2 | 1.05 (.26) | 1.08 (.33) | 1.07 (.32) | 1.03 (.17) | 1.05 (.26) | 1.04 (.24) |
| Household income3 | 3.1 (.98) | 3.1 (.90) | 3.1 (.92) | 3.0 (1.03) | 3.2 (.88) | 3.1 (.94) |
| Parental education level4 | 5.2 (.80) | 5.2 (.86) | 5.2 (.84) | 5.1 (1.03) | 5.2 (.75) | 5.2 (.85) |
Numbers shown are mean (SD) for continuous variables, and percentage of subjects in group for categorical variables. BDR: Bronchodilator responsiveness.
P<0.05 for the comparison by BMI group (all subjects).
P<0.05 for the comparison by treatment arm (budesonide vs. placebo/nedocromil) within each BMI group.
Presented as median (IQR) and analyzed as log10. Categorical variables:
Subjective report of compliance by the treating physician (most of the time; some of the time; or rarely).
Yearly combined household income (<$15,000; $15,000–$30,000; $30,000–$50,000; or >$40,000).
Highest parental education level (<8th grade; completed 8th; some high school; completed high school; some college or post-high school training; or completed college).