Table 1. Population characteristics.
| Population | CAMP Study | CAMP Replication | PACT Replication | SOCS Replication | IMPACT Replication |
|---|---|---|---|---|---|
| Trial | CAMP | CAMP | PACT | SOCS | IMPACT |
| Network | CAMP | CAMP | CARE | ACRN | ACRN |
| N | 388 | 188 | 142 | 56 | 80 |
| Race(s) | Caucasian | African American, Hispanic, Other | Caucasian | Caucasian | Caucasian |
| Age (SD) | 8.8 (2.1) | 9.2 (2.1) | 9.8 (2.2) | 30 (9.8) | 34 (11) |
| Sex (male) | 228 (59%) | 112 (60%) | 92 (65%) | 17 (30%) | 31 (39%) |
| ICS Treatment(s) | Budesonide | Budesonide | Fluticasone, salmeterol/fluticasone combination | Triamcinolone | Budesonide* |
| not ICS Treatment(s) | Placebo | Placebo | Montelukast | Placebo, salmeterol | Placebo* |
| Duration (weeks) | 207 | 207 | 57 | 30 | 60 |
| N ICS Group | 164 | 90 | 92 | 17 | 45 |
| N not ICS Group | 224 | 98 | 50 | 39 | 35 |
| FEVPPB (SD) | 95 (14) | 91 (14) | 98 (12) | 87 (15) | 88 (13) |
| LNPC20B (SD) | 0.048 (1.2) | 0.058 (1.1) | -0.3 (1.3) | 0.61 (0.57) | 0.85 (0.64) |
| BDRB (SD) | 11 (9.9) | 11 (9.8) | 8.4 (7.1) | Not Available | 9.8 (7.7) |
| SYMB (SD) | 0.63 (0.45) | 0.56 (0.43) | 0.59 (0.35) | Not Available | 0.18 (0.28) |
Definitions: CAMP = Childhood Asthma Management Program; PACT = Pediatric Asthma Controller Trial; IMPACT = The Improving Asthma Control Trial; SOCS = Salmeterol Or Corticosteroids Study; CARE = Childhood Asthma Research and Education; ACRN = Asthma Clinical Research Network; N ICS Group = Subjects treated with ICS or a combination therapy including ICS; N not ICS Group = Subjects treated with placebo, or a non-ICS therapy; SD = standard deviation; FEVPPB = FEV1 percent predicted at baseline; LNPC20B = natural log PC20 at baseline; BDRB = bronchodilator percent change at baseline; SYMB = average am symptoms as recorded in daily diary card at baseline.
IMPACT subjects had access to open-label budesonide as part of a symptom-based action plan and were subjected to a 10-to-14-day period of intense combined therapy that included ICS and oral steroids at the end of run-in and treatment phases of the study.