Table 1.
Demographic and baseline characteristics by study (budesonide/formoterol 160/4.5 μg and formoterol 4.5 μg arms only)
| Characteristic | SUN (n = 989) | SHINE (n = 561) | US3 (n = 807) | RISE (n = 1219) |
|---|---|---|---|---|
| Age, years | 63.0 (40–88) | 63.3 (41–89) | 63.1 (40–87) | 63.5 (40–87) |
| Male, n (%) | 631 (63.8) | 374 (66.7) | 490 (60.7) | 698 (57.3) |
| Female, n (%) | 358 (36.2) | 187 (33.3) | 317 (39.3) | 521 (42.7) |
| Race, n (%) | ||||
| White | 914 (92.4) | 523 (93.2) | 667 (82.8) | 1119 (91.8) |
| Black | 23 (2.3) | 20 (3.6) | 33 (4.1) | 39 (3.2) |
| Asian | 5 (0.5) | 2 (0.4) | 10 (1.2) | 17 (1.4) |
| Other | 47 (4.8) | 16 (2.9) | 96 (11.9) | 44 (3.6) |
| Former smoker, n (%) | 573 (57.9) | 319 (56.9) | 516 (63.9) | 655 (53.7) |
| Current smoker, n (%) | 416 (42.1) | 242 (43.1) | 291 (36.1) | 564 (46.3) |
| No. exacerbations in previous year | 1.8 (1–13) | 1.6 (0–8) | 1.7 (1–12) | 1.4 (1–7) |
| Post-FEV1, L | 1.18 (0.35–3.26) | 1.20 (0.30–3.29) | 1.11 (0.34–2.96) | 1.38 (0.34–3.6) |
| Post-FEV1, % predicted | 38.9 (13–92) | 39.3 (10–103) | 37.7 (12–77) | 48.7 (16–78) |
| FEV1/FVC ratio | 0.49 (0.20–0.85) | 0.48 (0.20–0.82) | 0.47 (0.16–1.00) | 0.49 (0.19–0.75) |
| Eosinophils, ×109/L, geometric mean (range) | 0.18 (0.01–1.47) | 0.18 (0.01–1.01) | 0.13 (0.01–2.51) | N/Aa |
| SGRQ total score | 54.9 (7–100) | 54.9 (14–100) | 57.5 (6–99) | 46.7 (0–97) |
Data presented as mean (range) unless otherwise stated
aLaboratory data was not assessed in RISE; therefore, no baseline data are available for eosinophils
FEV1 Forced expiratory volume in 1 s, FVC Forced vital capacity, N/A Not applicable, SGRQ St George’s Respiratory Questionnaire
For full baseline characteristics, see Additional file 1: Table S2