Table 2.
Baseline demographics in the ITT population
| Variable | Cic dose
|
Total
|
||
|---|---|---|---|---|
| 160 μg/day (N=120) | 320 μg/day (N=122) | 640 μg/day (N=125) | N=367 | |
| Age, years | ||||
| Mean (SD) | 43.2 (14.9) | 44.7 (15.6) | 45.3 (16.2) | 44.4 (15.6) |
| Sex, male | ||||
| n (%) | 48 (40.0) | 45 (36.9) | 44 (35.2) | 137 (37.3) |
| BMI, kg/m2 | ||||
| Mean (SD) | 27.3 (5.2) | 28.4 (6.4) | 27.1 (5.4) | 27.6 (5.7) |
| History of exacerbations, n (%) | ||||
| 0 | 70 (58.3) | 70 (57.4) | 63 (50.4) | 203 (55.3) |
| 1 | 17 (14.2) | 19 (15.6) | 21 (16.8) | 57 (15.5) |
| 2–3 | 4 (3.3) | 3 (2.5) | 4 (3.2) | 11 (3.0) |
| ≥4 | 0 | 0 | 0 | 0 |
| Unknown | 29 (24.2) | 30 (24.6) | 37 (29.6) | 96 (26.2) |
| Smoking status, n (%)* | ||||
| Never | 109 (90.8) | 102 (83.6) | 109 (87.2) | 320 (87.2) |
| Current | 1 (0.8) | 1 (0.8) | 1 (0.8) | 3 (0.8) |
| Former | 10 (8.3) | 19 (15.6) | 15 (12.0) | 44 (12.0) |
| Pre-study ICS dose, μg/day FP equivalent, n (%) | ||||
| <200 | 3 (2.5) | 3 (2.5) | 2 (1.6) | 8 (2.2) |
| Low: ≥200–≤250 | 40 (33.3) | 37 (30.3) | 42 (33.6) | 119 (32.4) |
| Medium: >250–≤500 | 72 (60.0) | 75 (61.5) | 70 (56.0) | 217 (59.1) |
| High: >500–≤1000 | 5 (4.2) | 7 (5.7) | 11 (8.8) | 23 (6.3) |
| ACQ score | ||||
| Mean (SD) | 2.24 (0.34) | 2.16 (0.38) | 2.20 (0.36) | 2.20 (0.36) |
| Pre-bronchodilator FEV1, % (predicted) | ||||
| Mean (SD) | 69.1 (18.47) | 74.4 (16.73) | 71.8 (18.44) | 71.8 (17.97) |
| Post-bronchodilator FEV1, % (predicted) | ||||
| Mean (SD) | 84.9 (19.30) | 90.2 (17.74) | 88.5 (17.71) | 87.9 (18.34) |
| FEV1 reversibility, % mean (SD) | 25.5 (17.02) | 23.0 (17.10) | 26.5 (20.78) | 25.0 (18.41) |
Note:
*
Percentages have been rounded to one decimal place and may not add up to 100%.
Abbreviations: ACQ, Asthma Control Questionnaire; BMI, body mass index; Cic, ciclesonide; FEV1, forced expiratory volume in 1 second; FP, fluticasone propionate; ICS, inhaled corticosteroid; ITT, intention-to-treat; SD, standard deviation.