Table 2.
Demographics and baseline characteristics (Safety Set and Full Analysis Set)
| Safety Set |
Full Analysis Set |
|||
|---|---|---|---|---|
| KB003 (n=78) |
Placebo (n=82) |
KB003 (n=74) |
Placebo (n=76) |
|
| Demographics | ||||
| Age, years | ||||
| Mean (SD) | 52.9 (11.95) | 53.1 (10.30) | 52.9 (11.84) | 53.3 (10.38) |
| Median | 53.5 | 54.0 | 53.5 | 54.0 |
| Range | 22–73 | 19–75 | 22–73 | 19–75 |
| Gender, n (%) | ||||
| Female | 44 (56.4) | 48 (58.5) | 44 (59.5) | 46 (60.5) |
| Male | 30 (43.6) | 34 (41.5) | 30 (40.5) | 30 (39.5) |
| Race, n (%) | ||||
| Asian | 2 (2.6) | 3 (3.7) | 2 (2.7) | 2 (2.6) |
| Black or African American | 7 (9.0) | 9 (11.0) | 6 (8.1) | 8 (10.5) |
| White | 69 (88.5) | 69 (84.1) | 66 (89.2) | 65 (85.5) |
| Other | 0 | 1 (1.2) | 0 | 1 (1.3) |
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 4 (5.1) | 7 (8.5) | 4 (5.4) | 6 (7.9) |
| Not Hispanic or Latino | 74 (94.9) | 75 (91.5) | 70 (94.6) | 70 (92.1) |
| Baseline characteristics | ||||
| Height, cm | ||||
| Mean (SD) | 168.37 (9.986) | 167.31 (8.477) | 167.97 (9.891) | 166.93 (8.405) |
| Median | 167.80 | 167.57 | 167.0 | 167.25 |
| Range | 148.0–190.5 | 152.0–185.4 | 148.0–188.0 | 152.0–185.4 |
| Weight, kg | ||||
| Mean (SD) | 83.05 (17.452) | 82.26 (16.951) | 82.44 (17.551) | 82.49 (17.006) |
| Median | 81.35 | 82.44 | 79.55 | 82.70 |
| Range | 42.6–120.0 | 48.0–123.0 | 42.6–120.0 | 48.0–123.0 |
| BMI, kg/m2 | ||||
| Mean (SD) | 29.340 (6.0031) | 29.365 (5.6555) | 29.259 (6.0292) | 29.592 (5.7388) |
| Median | 29.209 | 29.440 | 29.008 | 29.560 |
| Range | 13.46–46.99 | 17.99–42.79 | 13.46–46.99 | 17.99–42.79 |
| Percentage predicted FEV1 | ||||
| Mean (SD) | 56.636 (10.6441) | 56.483 (10.8880) | 56.440 (10.6499) | 57.638 (9.5821) |
| Median | 56.760 | 55.815 | 56.185 | 56.690 |
| Range | 34.59–77.82 | 25.09–77.45 | 34.59–77.82 | 39.81–77.45 |
| FEV1, L | ||||
| Mean (SD) | 1.774 (0.5536) | 1.713 (0.4678) | 1.752 (0.5425) | 1.736 (0.4595) |
| Median | 1.760 | 1.630 | 1.700 | 1.650 |
| Range | 0.97–3.03 | 0.69–3.10 | 0.97–3.03 | 1.09–3.10 |
| ACQ5 score | ||||
| Mean (SD) | 2.86 (0.705) | 2.87 (0.763) | 2.84 (0.711) | 2.89 (0.786) |
| Median | 2.86 | 2.86 | 2.86 | 2.86 |
| Range | 1.6–4.3 | 1.3–4.7 | 1.6–4.3 | 1.3–4.7 |
Percentages are based on the number of randomised participants in the Full Analysis Set or Safety Set in each treatment group. Baseline values are defined as the last non-missing values collected prior to first dose of study drug.
ACQ, Asthma Control Questionnaire; BMI, body mass index; FEV1, forced expiratory volume in 1 s.