Characteristic | Treatment group | ||||
---|---|---|---|---|---|
Fluticasone/formoterol 100/10 μg b.i.d. N = 115 | Fluticasone 100 μg b.i.d. N = 117 | Formoterol 10 μg b.i.d. N = 116 | Placebo b.i.d. N = 111 | Overall N = 459 | |
Gender, n (%) | |||||
Female | 72 (62.6) | 71 (60.7) | 63 (54.3) | 70 (63.1) | 276 (60.1) |
Male | 43 (37.4) | 46 (39.3) | 53 (45.7) | 41 (36.9) | 183 (39.9) |
Ethnic origin, n (%) | |||||
White/Caucasian | 89 (77.4) | 88 (75.2) | 83 (71.6) | 79 (71.2) | 339 (73.9) |
Black | 13 (11.3) | 16 (13.7) | 21 (18.1) | 22 (19.8) | 72 (15.7) |
Asian | 6 (5.2) | 4 (3.4) | 5 (4.3) | 4 (3.6) | 19 (4.1) |
Hispanic | 6 (5.2) | 8 (6.8) | 6 (5.2) | 5 (4.5) | 25 (5.4) |
Other | 1 (0.9) | 1 (0.9) | 1 (0.9) | 1 (0.9) | 4 (0.9) |
Age, years | |||||
Mean (SD) | 39.8 (14.54) | 38.3 (14.45) | 39.1 (15.26) | 38.1 (13.67) | 38.8 (14.47) |
Age categories, n (%) | |||||
12 to 17 years | 7 (6.1) | 9 (7.7) | 9 (7.8) | 6 (5.4) | 31 (6.8) |
≥ 18 years | 108 (93.9) | 108 (92.3) | 107 (92.2) | 105 (94.6) | 428 (93.2) |
Steroid use, n (%) | |||||
Freea | 59 (51.3) | 60 (51.3) | 58 (50.0) | 55 (49.5) | 232 (50.5) |
Requiringb | 56 (48.7) | 57 (48.7) | 58 (50.0) | 56 (50.5) | 227 (49.5) |
Prior ICS and ICS/LABA use, n (%) | |||||
ICS only | 31 (27.0) | 39 (33.3) | 30 (25.9) | 35 (31.5) | 135 (29.4) |
ICS and LABA | 25 (21.7) | 18 (15.4) | 28 (24.1) | 21 (18.9) | 92 (20.0) |
Duration of asthma, years c | |||||
Mean (SD) | 18.9 (13.40) | 20.6 (13.84) | 20.3 (14.48) | 21.4 (12.83) | 20.3 (13.64) |
FEV 1 % predictedd at baselinee | |||||
Mean (SD) | 73.2 (7.54) | 73.5 (8.14) | 73.2 (7.79) | 72.0 (7.97) | 73.0 (7.86) |
Median | 72.0 | 75.0 | 73.0 | 72.0 | 73.0 |
FEV1 at baselinee, L | |||||
Mean (SD) | 2.416 (0.5790) | 2.425 (0.6625) | 2.459 (0.6231) | 2.352 (0.6114) | 2.414 (0.6192) |
Median | 2.370 | 2.330 | 2.375 | 2.250 | 2.340 |
Reversibility at screening, % | |||||
n = 114 | n = 117 | n = 116 | n = 111 | n = 458 | |
Mean (SD) | 23.2 (10.1) | 22.8 (9.0) | 21.8 (8.4) | 22.8 (8.3) | 22.6 (9.0) |
Median | 19.3 | 19.5 | 18.7 | 20.0 | 19.2 |