Table 2. Demographic and other baseline characteristics of NCT00476099 and FORWARD studies.
|
NCT00476099
|
FORWARD
|
||||
|---|---|---|---|---|---|
| BDP/FF (N=232) | BUD/FF (N=238) | FF (N=233) | BDP/FF (N=595) | FF (N=591) | |
| Male, n (%) | 184 (79.3) | 194 (81.5) | 189 (81.1) | 408 (68.6) | 410 (69.4) |
| Female, n (%) | 48 (20.7) | 44 (18.5) | 44 (18.9) | 187 (31.4) | 181 (30.6) |
| Age, years, mean (s.d.) | 63.0 (9.0) | 64.1 (9.1) | 63.7 (8.8) | 64.6 (8.6) | 63.9 (8.6) |
| BMI, kg/m2, mean (s.d.) | 26.8 (5.3) | 26.6 (5.0) | 26.7 (4.7) | 26.5 (5.4) | 26.5 (5.3) |
| FEV1, L, mean (s.d.) | 1.22 (0.3) | 1.23 (0.3) | 1.22 (0.3) | 1.15 (0.3) | 1.16 (0.3) |
| FEV1, % pred. mean (s.d.) | 41.9 (5.8) | 42.3 (6.0) | 42.5 (5.9) | 41.86 (6.0) | 41.61 (6.0) |
| FVC, L, mean (s.d.) | 2.46 (0.6) | 2.47 (0.6) | 2.46 (0.6) | 2.46 (0.7) | 2.52 (0.7) |
| FEV1/FVC, mean (s.d.) | 0.51 (0.1) | 0.51 (0.1) | 0.51 (0.1) | 0.48 (0.1) | 0.48 (0.1) |
| Disease duration, years, mean (s.d.) | 9.4 (7.0) | 9.9 (7.8) | 9.8 (6.7) | 7.9 (5.9) | 7.5 (5.7) |
| Exacerbations/patient, mean (s.d.) | 1.7 (1.0) | 1.7 (1.0) | 1.8 (1.0) | 1.5 (0.9) | 1.4 (0.9) |
| Current smokers, n (%) | 90 (38.8) | 86 (36.1) | 87 (37.3) | 231 (38.8) | 237 (40.1) |
| Ex-smokers, n (%) | 142 (61.2) | 152 (63.9) | 146 (62.7) | 364 (61.2) | 354 (59.9) |
| Pack-years, mean (s.d.) | 37.3 (14.1) | 37.8 (14.6) | 39.7 (19.1) | 43.1 (23.5) | 42.7 (22.9) |
| Tiotropium users at randomisation, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 318 (53.4) | 298 (50.4) |
| SGRQ total, mean (s.d.) | 51.0 (15.4) | 49.7 (15.8) | 50.6 (16.2) | 47.3 (17.9) | 48.0 (17.2) |
Abbreviations: BMI, body mass index; FVC, forced vital capacity; SGRQ, St George's Respiratory Questionnaire.