Table 2.
Summary of Baseline Characteristics, by Study
| Study A | Study B | Study C | ||||
|---|---|---|---|---|---|---|
| Country, n (%) | USA Mexico Germany Hungary Greece Bulgaria Denmark Romania Iceland |
758 (43.6) 82 (4.7) 197 (11.3) 293 (16.8) 37 (2.1) 136 (7.8) 76 (4.4) 139 (8.0) 22 (1.3) |
USA Czech Republic South Africa Poland Netherlands |
659 (41.8) 259 (16.1) 124 (7.7) 473 (29.4) 89 (5.0) |
USA Argentina Brazil South Africa Chile Colombia Mexico Peru Venezuela |
481 (46.2) 183 (17.6) 81 (7.8) 161 (15.4) 43 (4.1) 19 (1.8) 52 (5.0) 17 (1.6) 5 (0.6) |
| Exacerbation historya, median (range) | 1.0 (0–11) | 1.0 (0–10) | 1.0 (1–12) | |||
| Male sex, % | 64.0 | 68.1 | 62.9 | |||
| Race, % | ||||||
| Caucasian | 92.1 | 93.5 | 81.8 | |||
| Black | 2.4 | 3.8 | 3.6 | |||
| Oriental | 0.5 | 0.4 | – | |||
| Asian | – | – | 1.2 | |||
| American Indian or Alaska Native | – | – | 0.2 | |||
| Other | 5.0 | 2.3 | 13.2 | |||
| Season of year at treatment start, % | ||||||
| Autumn | 25.4 | 27.8 | 8.3 | |||
| Spring | 23.9 | 16.6 | 42.4 | |||
| Summer | 34.9 | 35.9 | 22.3 | |||
| Winter | 15.8 | 19.7 | 27.2 | |||
| Breathlessness scoreb, mean (SD) | 2.15 (0.66) | 2.11 (0.67) | 1.84 (0.77) | |||
| Sleep scoreb, mean (SD) | 1.01 (0.88) | 0.98 (0.86) | 1.19 (0.87) | |||
| Sputum scoreb, mean (SD) | 1.44 (0.89) | 1.45 (0.84) | 1.47 (0.85) | |||
| Cough scoreb, mean (SD) | 1.86 (0.85) | 1.81 (0.82) | 1.79 (0.8) | |||
| Eosinophils [x109/L], mean (SD) | 0.24 (0.19) | 0.23 (0.19) | 0.19 (0.3) | |||
| FEV1 [L], mean (SD) | 1.05 (0.40) | 1.05 (0.40) | 1.01 (0.41) | |||
| FVC [L], Mean (SD) | 2.16 (0.72) | 2.25 (0.76) | 2.18 (0.75) | |||
| FEV1/FVC, mean (SD) | 0.49 (0.12) | 0.48 (0.12) | 0.47 (0.12) | |||
Notes: aNumber of exacerbations during previous year. bBaseline scores were averaged for each patient over the 14-day run-in period.
Abbreviations: FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; n, number; SD, standard deviation.