Table 2.
Patient demographics and baseline characteristics
| Indacaterol | Indacaterol + tiotropium | Other LABA | Tiotropium | Other LABA + tiotropium | Total | |
|---|---|---|---|---|---|---|
| (n=1,179) | (n=167) | (n=68) | (n=271) | (n=25) | (N=1,710) | |
| Age, years | ||||||
| Mean (SD) | 58.6 (11.79) | 62.5 (10.36) | 55.3 (9.77) | 57.6 (12.29) | 59.8 (9.37) | 58.7 (11.71) |
| Age group, n (%) | ||||||
| <65 years | 818 (69.4) | 94 (56.3) | 56 (82.4) | 192 (70.8) | 16 (64.0) | 1,176 (68.8) |
| ≥65 years | 361 (30.6) | 73 (43.7) | 12 (17.6) | 79 (29.2) | 9 (36.0) | 534 (31.2) |
| Sex, n (%) | ||||||
| Male | 875 (74.2) | 143 (85.6) | 51 (75.0) | 218 (80.4) | 22 (88.0) | 1,309 (76.5) |
| Race, n (%) | ||||||
| Caucasian | 819 (69.5) | 75 (44.9) | 62 (91.2) | 163 (60.1) | 25 (100) | 1,144 (66.9) |
| Asian | 320 (27.1) | 92 (55.1) | 5 (7.4) | 97 (35.8) | 0 | 514 (30.1) |
| Other | 35 (3.0) | 0 | 1 (1.5) | 11 (4.1) | 0 | 47 (2.7) |
| Black | 5 (0.4) | 0 | 0 | 0 | 0 | 5 (0.3) |
| Smoking history, pack-years | ||||||
| n | 1,168 | 145 | 68 | 268 | 25 | 1,674 |
| Mean (SD) | 39.3 (28.03) | 34.0 (23.71) | 33.3 (13.90) | 34.2 (18.90) | 42.0 (28.6) | 37.8 (26.05) |
| Smoking history, n (%) | ||||||
| Never smoked | 6 (0.5) | 9 (5.4) | 0 | 3 (1.1) | 0 | 18 (1.1) |
| Ex-smoker | 361 (30.6) | 88 (52.7) | 13 (19.1) | 81 (29.9) | 10 (40.0) | 553 (32.3) |
| Current smoker | 812 (68.9) | 70 (41.9) | 55 (80.9) | 187 (69.0) | 15 (60.0) | 1,139 (66.6) |
| Postbronchodilator FEV1, % predicted | ||||||
| n | 520 | 120 | 27 | 109 | 22 | 798 |
| Mean (SD) | 60.8 (19.23) | 52.4 (18.10) | 64.5 (12.06) | 60.8 (20.97) | 54.7 (15.47) | 59.5 (19.25) |
| Postbronchodilator FEV1/FVC, % | ||||||
| n | 517 | 110 | 27 | 111 | 22 | 787 |
| Mean (SD) | 61.2 (8.97) | 60.0 (12.16) | 61.1 (8.29) | 62.2 (9.13) | 60.6 (11.08) | 61.2 (9.53) |
| GOLD stage airflow limitation at study entry (based on GOLD 2009), n (%) | ||||||
| GOLD I | 52 (4.4) | 15 (9.0) | 4 (5.9) | 7 (2.6) | 0 | 78 (4.6) |
| GOLD II | 957 (81.2) | 76 (45.5) | 54 (79.4) | 231 (85.2) | 19 (76.0) | 1,337 (78.2) |
| GOLD III | 135 (11.5) | 57 (34.1) | 9 (13.2) | 27 (10.0) | 5 (20.0) | 233 (13.6) |
| GOLD IV | 35 (3.0) | 19 (11.4) | 1 (1.5) | 6 (2.2) | 1 (4.0) | 62 (3.6) |
| COPD exacerbations in past 12 months | ||||||
| Number | 2,191 | 316 | 144 | 378 | 43 | 3,072 |
| Mean (SD) | 1.9 (3.35) | 1.9 (5.45) | 2.1 (2.28) | 1.4 (2.20) | 1.7 (1.43) | 1.8 (3.41) |
| Hospitalizations due to COPD exacerbations in past 12 months | ||||||
| Number | 553 | 51 | 21 | 99 | 7 | 731 |
| Mean (SD) | 0.5 (0.91) | 0.3 (0.82) | 0.3 (0.63) | 0.4 (0.77) | 0.3 (0.68) | 0.4 (0.87) |
|
| ||||||
| (n=1,103) | (n=142) | (n=68) | (n=250) | (n=25) | (N=1,588) | |
| CCQ overall score, points | ||||||
| n | 1,079 | 142 | 65 | 245 | 25 | 1,556 |
| Mean (SD) | 2.4 (1.02) | 2.7 (1.01) | 2.2 (1.04) | 2.3 (0.94) | 3.3 (1.14) | 2.4 (1.02) |
| CCQ symptoms domain score, points | ||||||
| n | 1,083 | 142 | 65 | 246 | 25 | 1,561 |
| Mean (SD) | 2.9 (1.03) | 2.9 (1.20) | 2.6 (1.08) | 2.7 (1.09) | 3.7 (0.98) | 2.8 (1.06) |
Note: GOLD staging was based on information reported by the study physician at the baseline visit. The bold letters indicate the total number of participants in each group.
Abbreviations: CCQ, clinical COPD questionnaire; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; GOLD, Global initiative for chronic Obstructive Lung Disease; LABA, long-acting β2-agonist; SD, standard deviation.