Table 1.
Baseline Characteristics by ICS Use at Screening
| Prior ICS Use (n = 7,360) | No Prior ICS Use (n = 2,995) | |
|---|---|---|
| Age, mean (SD), yr | 65.3 (8.2) | 65.2 (8.4) |
| Sex, M, n (%) | 4,813 (65) | 2,057 (69) |
| BMI, mean (SD), kg/m2 | 26.7 (6.1) | 26.5 (6.1) |
| Current smoker, n (%) | 2,408 (33) | 1,179 (39) |
| Former smoker, n (%) | 4,952 (67) | 1,816 (61) |
| SGRQ total score, mean (SD) | 51.5 (16.84) | 48.6 (16.76) |
| Prebronchodilator FEV1, mean (SD), L | 1.14 (0.46) | 1.24 (0.49) |
| Prebronchodilator FEV1, mean (SD), % predicted | 40.9 (14.2) | 43.9 (14.8) |
| Post-bronchodilator FEV1, mean (SD), L | 1.24 (0.47) | 1.35 (0.50) |
| Post-bronchodilator FEV1, mean (SD), % predicted | 44.7 (14.7) | 47.7 (15.1) |
| Post-bronchodilator FEV1% predicted < 50%, n (%) | 4,861 (66) | 1,745 (58) |
| Reversibility, mean (SD), % | 10.6 (12.3) | 10.0 (12.6) |
| Moderate/severe exacerbations in the prior year, n (%) | ||
| 0 | 5 (<1) | 4 (<1) |
| 1 | 3,360 (46) | 1,331 (44) |
| ≥2 | 3,995 (54) | 1,660 (55) |
| Severe exacerbations in the prior year, n (%) | ||
| 0 | 5,343 (73) | 2,341 (78) |
| 1 | 1,725 (23) | 575 (19) |
| ≥2 | 292 (4) | 79 (3) |
Definition of abbreviations: BMI = body mass index; ICS = inhaled corticosteroid; SGRQ = St. George’s Respiratory Questionnaire.