Table 1.
Participant characteristics
| Treatment Group (n = 295) |
P Value | |||
|---|---|---|---|---|
| Lansoprazole (n = 138) |
||||
| Placebo (n = 157) | EM (n = 94) | PM (n = 44) | ||
| n | 157 | 94 | 44 | |
| Age (yr), mean (SD) | 11 (3) | 11 (3) | 12 (3) | 0.058 |
| Male | 102 (65%) | 56 (60%) | 24 (55%) | 0.398 |
| Race/ethnicity | 0.317 | |||
| Black | 79 (50) | 40 (43) | 29(66) | |
| White | 52 (33) | 36 (38) | 11(25) | |
| Hispanic | 17 (11) | 13 (14) | 3 (7) | |
| Other | 9 (6) | 5 (5) | 1 (2) | |
| Asthma characteristics | ||||
| Age at onset (yr), mean (SD) | 3 (3) | 3 (3) | 4 (4) | 0.425 |
| Urgent asthma care in past year | 109 (69) | 69 (73) | 36 (82) | 0.259 |
| Steroids in past year | 98 (62) | 69 (73) | 33 (75) | 0.107 |
| Rescue inhaler 2 or more times/wk | 118 (75) | 71 (76) | 31 (70) | 0.977 |
| Daily use of ICS/LABA | 90 (57) | 50 (53) | 26 (60) | 0.476 |
| Daily use of leukotriene modifier | 86 (55) | 53 (56) | 26 (59) | 0.873 |
| Baseline asthma scores, mean (SD) | 156 | 94 | 44 | |
| ACQ at screening* | 1.6 (0.8) | 1.6 (0.9) | 1.5 (0.8) | 0.626 |
| ACQ at randomization* | 1.2 (0.8) | 1.2 (0.8) | 1.1 (0.8) | 0.702 |
| ACT (12–17 yr) (n = 133)† | 19 (14) | 19 (4) | 20 (4) | 0.403 |
| Children’s ACT (5–11 yr) (n = 156)‡ | 20 (4) | 20 (4) | 20 (3) | 0.801 |
| Pulmonary function, mean (SD) | 157 | 94 | 44 | |
| FEV1, percent predicted | 92 (15) | 91 (17) | 92 (16) | 0.757 |
| FVC, percent predicted | 101 (15) | 100 (13) | 102 (15) | 0.821 |
| Change in FEV1 postbronchodilator | 8.5 (10.9) | 10.5 (10.9) | 11.1 (10.3) | 0.059 |
| Change in FVC postbronchodilator | 2.0 (6.6) | 3.4 (5.6) | 2.5 (5.4) | 0.041 |
| Other chronic conditions | ||||
| GERD | 2 (1) | 2 (2) | 1 (2) | 0.701 (F) |
| Eczema | 62 (39) | 42 (45) | 21 (48) | 0.534 |
| Rhinitis | 80 (51) | 65 (69) | 28 (64) | 0.014 |
| Food allergies | 43 (27) | 22 (23) | 11 (25) | 0.777 |
| Allergies worsen asthma | 124 (79) | 73 (78) | 38 (86) | 0.473 |
| Exposed to secondhand smoke | 52 (33) | 26 (28) | 9 (20) | 0.238 |
| Positive pH probes | 20/53 (38) | 18/36 (50) | 8/20 (40) | 0.504 |
| GERD symptom score,§ median (IQR) | 9 (2, 22) | 9 (1, 29) | 6 (3, 16) | 0.909 |
| Number of symptoms, median (IQR) | 2 (1, 4) | 1 (0, 3) | 1 (0, 2) | 0.719 |
Definition of abbreviations: ACQ = Asthma Control Questionnaire; ACT = Asthma Control Test; EM = extensive metabolizer; F = Fisher exact test; GERD = gastroesophageal reflux disease; ICS = inhaled corticosteroid; IQR = interquartile range; LABA = long-acting β-agonist; PM = poor metabolizer.
Note: Values represent counts (%) unless otherwise indicated.
*
Scores range from 0 to 6, with higher scores indicating worse asthma.
†
Scores range from 5 to 25, with lower scores indicating worse asthma.
‡
Scores range from 0 to 27, with lower scores indicating worse asthma.
§
Scores range from 0 to 441, with higher values suggesting worse symptoms.