Table 1 Patient demographic and baseline clinical characteristics (safety population)
Indacaterol 150 μg o.d. N = 211 | Placebo N = 205 | |
|---|---|---|
Age, in years, mean (SD) | 62.9 (9.89) | 63.2 (9.62) |
Sex, n (%) | ||
Male | 108 (51.2) | 110 (53.7) |
Female | 103 (48.8) | 95 (46.3) |
Race, n (%) | ||
Caucasian | 194 (91.9) | 191 (93.2) |
Black | 12 (5.7) | 10 (4.9) |
Asian | 1 (0.5) | 1 (0.5) |
Native American | 2 (0.9) | 1 (0.5) |
Other | 2 (0.9) | 2 (1.0) |
Duration of COPD, in years, mean (SD) | 6.6 (6.86) | 7.3 (5.64) |
Duration of COPD, in years, n (%) | ||
<1 | 38 (18.0) | 18 (8.8) |
1—5 | 74 (35.1) | 69 (33.7) |
>5—10 | 57 (27.0) | 69 (33.7) |
>10—15 | 23 (10.9) | 30 (14.6) |
>15—20 | 9 (4.3) | 12 (5.9) |
>20 | 10 (4.7) | 7 (3.4) |
Severity of COPD*, n (%) | ||
At risk | 0 (0.0) | 1 (0.5) |
Mild | 7 (3.3) | 10 (4.9) |
Moderate | 119 (56.4) | 117 (57.1) |
Severe | 84 (39.8) | 76 (37.1) |
Very severe | 1 (0.5) | 1 (0.5) |
Smoking history, n (%) | ||
Ex-smoker | 103 (48.8) | 97 (47.3) |
Current smoker | 108 (51.2) | 108 (52.7) |
Number of pack years†, mean (SD) | 53.5 (26.84) | 60.5 (54.12) |
FEV1 (L), mean (SD)‡ | 1.5 (0.53) | 1.5 (0.51) |
FEV1 (% predicted), mean (SD)‡ | 54.4 (13.38) | 55.8 (14.08) |
FEV1/FVC (%), mean (SD)‡ | 53.5 (9.84) | 53.5 (10.36) |
FEV1 reversibility (%), mean (SD) | 16.4 (17.31) | 16.6 (19.44) |
Concomitant ICS, n (%) | 61 (28.9) | 70 (34.1) |