Table 2.
Demographics and Baseline Characteristics
| Asthma study | COPD study | |||
|---|---|---|---|---|
| Demographic or baseline characteristic | Placebo (N=26) | Inhaled loxapine (N=26) | Placebo (N=27) | Inhaled loxapine (N=26) |
| Gender, n (%) | ||||
| Female | 11 (42.3%) | 16 (61.5%) | 15 (55.6%) | 15 (57.7%) |
| Male | 15 (57.7%) | 10 (38.5%) | 12 (44.4%) | 11 (42.3%) |
| Age (years) | ||||
| Mean (SD) | 33.2 (11.46) | 40.0 (11.53) | 56.7 (6.50) | 57.5 (6.58) |
| Median | 29 | 38.5 | 57 | 58.5 |
| Minimum, maximum | 18, 61 | 18, 57 | 40, 68 | 40, 66 |
| Race, n (%) | ||||
| Caucasian | 20 (76.9%) | 21 (80.8%) | 20 (74.1%) | 24 (92.3%) |
| Black | 5 (19.2%) | 0 (0.0%) | 7 (25.9%) | 2 (7.7%) |
| Hispanic | 1 (3.8%) | 4 (15.4%) | ||
| Other | 0 (0.0%) | 1 (3.8%) | ||
| Height (cm) | ||||
| Mean (SD) | 172.8 (10.46) | 168.8 (10.72) | 169.1 (10.20) | 167.0 (10.59) |
| Median | 174.6 | 168.0 | 168.9 | 167.95 |
| Minimum, maximum | 154.9, 190.5 | 150, 196 | 155.6, 190.5 | 137.2, 186.1 |
| Weight (kg) | ||||
| Mean (SD) | 84.4 (14.33) | 77.4 (16.76) | 76.87 (16.981) | 79.54 (14.141) |
| Median | 82.7 | 73 | 77.3 | 78.65 |
| Minimum, maximum | 60, 110 | 55.3, 110 | 52.7, 113.6 | 52.8, 110.9 |
| Smoking history, n (%) | ||||
| Never smoked | 23 (88.5%) | 20 (76.9%) | 0 | 0 |
| Ex-smoker | 3 (11.5%) | 6 (23.1%) | 11 (40.7%) | 9 (34.6%) |
| Current smoker | 0 | 0 | 16 (59.3%) | 17 (65.4%) |
| Screening pre-bronchodilator FEV1 (% of predicted): median (range) | 89.5% (60.0–105.0%) | 82.5% (66.0–117.0%) | na | na |
| Asthma classification at screening (per NHLBI),(20)n (%) | ||||
| FEV1 ≥80% (well controlled) | 18 (69.2%) | 17 (65.4%) | na | na |
| FEV1 <80% (not well controlled) | 8 (30.8%) | 9 (34.6%) | na | na |
| Screening post-bronchodilator FEV1 (% of predicted): median (min, max) | na | na | 55.0% (40.0–96.0%) | 55.0% (40.0–89.0%) |
| COPD severity at screening (GOLD criteria),(21)n (%) | ||||
| Mild (FEV1 ≥80% of predicted and FEV1/FVC ≤0.7) | na | na | 4 (14.8%) | 2 (7.7%) |
| Moderate (FEV1 50% to <80% of predicted) | na | na | 15 (55.6%) | 15 (57.7%) |
| Severe (FEV1 30% to <5.0% of predicted) | na | na | 8 (29.6%) | 9 (34.6%) |
GOLD, Global Initiative for Chronic Obstructive Lung Disease; na, not applicable; NHLBI, National Heart, Lung, and Blood Institute.