Table 1.
Baseline Characteristics
| Treatment | ||
|---|---|---|
| Placebo | Esomeprazole | |
| Demographic Characteristics – N | 199 | 203 |
| Mean age at randomization, yr ± SD | 42 ± 13 | 42 ± 13 |
| Males (% of group) | 28 | 36 |
| Race or ethnic group (% of group) | ||
| White | 52 | 50 |
| Black | 37 | 39 |
| Hispanic | 9 | 9 |
| Other | 3 | 2 |
| Former smoker (% of group) | 20 | 15 |
| Mean BMI, kg/m2 ± SD | 32 ± 8 | 32 ± 9 |
| BMI >=30 kg/m2 (% of group) | 54 | 50 |
| Asthma Characteristics | ||
| Mean age of asthma onset yr ± SD | 17 ± 17 | 17 ± 16 |
| Use of inhaled short-acting beta-agonist (MDI/Neb) ≥ 2 times/week (% of group) | 83 | 79 |
| Unscheduled health care visit in past year (%of group) | 63 | 54 |
| Oral corticosteroids for asthma in past year (%of group) | 51 | 47 |
| Daily use of ICS (% of group) | 100 | 100 |
| Fluticasone/salmeterol (% of group) | 75 | 79 |
| Mean ACQ (↓) (score range: 0–6) ± SD | 1.9 ± 0.8 | 1.8 ± 0.8 |
| Mean ASUI (↑) (score range: 0–1) ± SD | 0.74 ± 0.18 | 0.76 ± 0.15 |
| Mean AQL (↑) (score range: 1–7) ± SD | 4.7 ± 1.2 | 4.7 ± 1.2 |
| SF-36 Quality of Life (↑) (score range: 0–100) - N | 199 | 202 |
| Mean physical score ± SD | 42 ± 10 | 43 ± 10 |
| Mean emotional score ± SD | 49 ± 10 | 50 ± 11 |
| Mean Pulmonary Function Measures - N | 198 | 203 |
| Pre-BD FEV1 (%predicted ± SD) * | 78 ± 15 | 76 ± 15 |
| Pre-BD FVC (%predicted ± SD) * | 87 ± 16 | 87 ± 14 |
| FEV1 %change post-BD ± SD | 10 ± 10 | 11 ± 16 |
| FVC %change post-BD ± SD | 5 ± 8 | 6 ± 11 |
| Peak flow rate (L/min ± SD) | 363 ± 97 | 357 ± 107 |
| PC20 mg/mL - N | 92 | 83 |
| mean ± SD | 2.8 ± 4.0 | 3.6 ± 4.4 |
| PC20 contraindicated n (% of group) | 103 (52) | 117 (59) |
| pH probe results – N | 151 | 152 |
| Positive (% of group) | 41 | 39 |
| GERD Symptom Assessment Scale - N | 199 | 203 |
| Mean number of symptoms (0–15) ) ± SD | 7 ± 3 | 6 ± 4 |
| Mean distress score (↓) (score range: 0–3) ± SD | 0.60 ± 0.46 | 0.51 ± 0.47 |
| Other conditions - N | 199 | 203 |
| Self-reported GERD (% of group) | 19 | 10 |
| Eczema (% of group) | 20 | 10 |
| Sinusitis (% of group) | 43 | 34 |
| Rhinitis (% of group) | 61 | 58 |
| Food allergies (% of group) | 24 | 15 |
| Allergies worsen asthma (% of group) | 78 | 78 |
KEY: BMI = Body Mass Index. ACQ = Asthma Control Questionnaire. ASUI = Asthma Symptom Utility Index. AQL = Asthma Quality of Life. ↑ = higher score is better, ↓ = lower score is better, FEV1 = Forced expiratory volume in 1 second, FVC = Forced vital capacity, BD = bronchodilator, SD = standard deviation, GERD = gastroesphogeal reflux disease, SF-36 = RAND 36 item health survey.
*
Predicted values for FEV1 and FVC are taken from: Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999;159:179–87.