Table 1.
Patient demographics and baseline characteristics
| Treatment group (MDI-administered; BID) |
|||||
|---|---|---|---|---|---|
| MF/F | FP/S | MF/F | FP/S | ||
| 200/10 μg | 250/50 μg | 400/10 μg | 500/50 μg | Total | |
| Characteristics | (n = 141) | (n = 68) | (n = 130) | (n = 65) | (n = 404) |
| Age, mean (SD), years | 32.7(15.2) | 32.4(14.9) | 39.3(14.5) | 37.1(15.0) | 35.5(15.2) |
| Sex, n (%) | |||||
| Women | 92(65) | 38(56) | 86(66) | 40(62) | 256 (63) |
| Men | 49 (35) | 30 (44) | 44 (34) | 25(38) | 148 (37) |
| Race, n (%) | |||||
| White | 68 (48) | 32 (49) | 60(46) | 32(49) | 190(47) |
| Nonwhite (multiracial) | 73(52) | 38 (56) | 70 (54) | 33 (51) | 214 (53) |
| Body mass index, mean (SD) (kg/m2) | 25.78 (4.96) | 25.56(5.51) | 26.47 (4.27) | 26.59 (5.54) | 25.78 (4.96) |
| Asthma duration, mean (SD) (years) | 15.32(11.92) | 17.28 (12.5) | 19.38(13.17) | 18.10(12.30) | 17.28(12.5) |
| Baseline FEY1 mean (SD) (L) | 2.56(0.76) | 2.53 (0.8) | 2.31(0.72) | 2.26(0.71) | 2.42(0.76) |
| Baseline FEY1 mean (SD) (% predicted) | 80.45(15.94) | 78.14(16.26) | 74.47 (15.80) | 72.15(17.66) | 76.78(16.49) |
| FEV1, mean (SD) (% reversibility) | 21.28(9.54) | 23.70(11.74) | 24.05(11.68) | 24.77 (13.86) | 23.06(11.27) |
| Prior ICS use, n (%)* | |||||
| Beclomethasone | 40(28) | 15 (23) | 28(22) | 15(23) | 97(24) |
| Budesonide | 44(31) | 24(35) | 25(19) | 13 (20) | 106(26) |
| Ciclesonide | 1(1) | 1(1) | 3(2) | 0 | 5(1) |
| Fluticasone | 38(27) | 29 (32) | 46(35) | 24 (37) | 129 (32) |
| Mometasone | 1(1) | 0 | 5(4) | 1(2) | 7(2) |
| ICS + LABA, n (%)* | |||||
| Budesonide/formoterol | 3(2) | 1(1) | 1(1) | 0 | 5(1) |
| Fluticasone/salmeterol | 21 (15) | 11 (16) | 31 (24) | 16 (25) | 79 (20) |
| Prior tobacco use, n (%) | 17(12) | 4(6) | 15(12) | 9(14) | 45(11) |
*
Patients could have used >1 ICS and/or ICS + LABA during the 3 months before randomization. BID, twice daily; FEV1, forced expiratory volume in 1 second; FP/S, fluticasone propionate/salmeterol; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; MDI, metered-dose inhaler; MF/F, mometasone furoate/formoterol.