Table 1.
Baseline Demographic and Clinical Characteristics by Treatment Assignment
| Baseline Characteristic | OVERALL (n, %) | PLACEBO (n, %) | RESCUE (n, %) | DAILY (n, %) | COMBINED (n, %) |
|---|---|---|---|---|---|
| All Subjects | 288 (100) | 74 (100) | 71 (100) | 72 (100) | 71 (100) |
| Male | 159 (55.2) | 41 (55.4) | 37 (52.1) | 42 (58.3) | 39 (54.9) |
| Age 6-11 years | 188 (65.3) | 50 (67.6) | 47 (66.2) | 47 (65.3) | 44 (62.0) |
| White | 217 (75.3) | 59 (79.7) | 57 (80.3) | 51 (70.8) | 50 (70.4) |
| Hispanic or Latino | 103 (35.8) | 26 (35.1) | 27 (38.0) | 26 (36.1) | 24 (33.8) |
| Diagnosis ≤3 years | 139 (48.9) | 37 (50.7) | 34 (47.9) | 33 (46.5) | 35 (50.7) |
| Parental Asthma | 131 (48.5) | 36 (51.4) | 33 (46.5) | 30 (46.2) | 32 (50.0) |
| Eczema | 143 (49.7) | 36 (48.6) | 37 (52.1) | 34 (47.2) | 36 (50.7) |
| Skin test positive* | 220 (78.0) | 54 (73.0) | 57 (85.1) | 52 (74.3) | 57 (80.3) |
| IgE level* >350 K/μL | 85 (30.5) | 18 (24.7) | 25 (36.8) | 25 (36.2) | 17 (24.6) |
| FEV1 reversibility ≥12% | 59 (20.5) | 14 (18.9) | 16 (22.5) | 15 (20.8) | 14 (19.7) |
| PC20 ≤12.5 mg/dL | 191 (66.3) | 52 (70.3) | 49 (69.0) | 44 (61.1) | 46 (64.8) |
| FENO level* < 25 ppb | 228 (83.2) | 57 (80.3) | 60 (87.0) | 62 (87.3) | 49 (77.8) |
| Complete run-in control | 183 (63.5) | 51 (68.9) | 47 (66.2) | 39 (54.2) | 46 (64.8) |
| ≥1 OCS past year | 83 (28.8) | 21 (28.4) | 24 (33.8) | 19 (26.4) | 19 (26.8) |
*
Indicates missing data: skin test, 6 missing; IgE, 9 missing; eNO, 14 missing. Abbreviations: FENO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second ; IgE, serum immunoglobulin E; OCS, oral corticosteroid requiring exacerbation; PC20, concentration of methacholine causing a 20% decline in FEV1.