Patient demographic data and other characteristics at baseline (safety population)
| Indacaterol 300 μg | Indacaterol 600 μg | Formoterol | Placebo | |
| n=437 | n=425 | n=434 | n=432 | |
| Age, years | 64.0 (57.0, 71.0) | 63.0 (57.0, 69.0) | 64.0 (58.0, 69.0) | 63.0 (57.5, 69.0) |
| Male sex, n (%) | 351 (80.3) | 327 (76.9) | 348 (80.2) | 352 (81.5) |
| BMI, kg/m2 | 25.9 (23.3, 28.9) | 26.0 (23.0, 29.7) | 25.7 (22.9, 29.0) | 26.4 (23.1, 30.0) |
| COPD severity, n (%)* | ||||
| At risk† | 9 (2.1) | 3 (0.7) | 7 (1.6) | 10 (2.3) |
| Mild† | 2 (0.5) | 6 (1.4) | 7 (1.6) | 10 (2.3) |
| Moderate | 226 (51.7) | 212 (49.9) | 226 (52.1) | 216 (50.0) |
| Severe | 190 (43.5) | 188 (44.2) | 182 (41.9) | 186 (43.1) |
| Very severe | 9 (2.1) | 15 (3.5) | 10 (2.3) | 9 (2.1) |
| ICS users, n (%) | 243 (55.6) | 226 (53.2) | 221 (50.9) | 224 (51.9) |
| Smoking history, pack-years | 40.0 (30.0, 53.0) | 40.0 (30.0, 58.0) | 40.0 (30.0, 50.0) | 43.0 (31.0, 53.5) |
| History of, n (%) | ||||
| CCV condition | 80 (18.3) | 93 (21.9) | 88 (20.3) | 82 (19.0) |
| Diabetes mellitus | 33 (7.6) | 39 (9.2) | 37 (8.5) | 50 (11.6) |
| Hypertension | 227 (51.9) | 204 (48.0) | 213 (49.1) | 216 (50.0) |
| Hyperlipidaemia | 145 (33.2) | 138 (32.5) | 133 (30.6) | 131 (30.3) |
| FEV1, % predicted‡ | 51.5 (42.2, 62.9) | 50.8 (41.2, 60.2) | 52.5 (41.2, 63.1) | 52.0 (41.9, 63.6) |
| FEV1/FVC, %‡ | 50.7 (43.5, 59.5) | 51.1 (43.8, 59.1) | 51.2 (43.5, 59.0) | 52.0 (44.1, 60.5) |
| Prebronchodilator FEV1, l | 1.29 (1.01, 1.58) | 1.28 (0.98, 1.60) | 1.30 (1.00, 1.62) | 1.28 (1.00, 1.70) |
| Postbronchodilator FEV1, l‡ | 1.44 (1.14, 1.78) | 1.41 (1.11, 1.75) | 1.47 (1.12, 1.80) | 1.44 (1.12, 1.85) |
| Reversibility, %‡ | 9.8 (3.0, 18.3) | 10.9 (3.8, 20.6) | 10.1 (3.4, 18.3) | 10.8 (4.7, 19.1) |
| SGRQ total score§ | 43 (32, 58) | 44 (31, 56) | 44 (32, 57) | 43 (30, 57) |
| BDI total score§ | 6.0 (6.0, 8.0) | 6.0 (5.0, 8.0) | 6.0 (5.0, 8.0) | 6.0 (5.0, 8.0) |
| 6-min walking distance, m§ | 379 (300, 448) | 370 (300, 447) | 380 (300, 450) | 390 (307, 444) |
| BODE index§ | 3.0 (2.0, 4.0) | 3.0 (1.0, 4.0) | 3.0 (1.0, 4.0) | 3.0 (2.0, 4.0) |
Data are median (upper and lower quartiles) unless stated otherwise.
↵* COPD severity based on GOLD 2005 criteria.
↵† Patients enrolled before a protocol amendment of entry criteria stipulating postbronchodilator rather than prebronchodilator spirometry values.
↵‡ Measured 30 min after salbutamol 400 μg inhalation. Reversibility was calculated as the difference between the prebronchodilator and postbronchodilator values of FEV1 (in litres) as a percentage of the prebronchodilator value.
↵§ Reported for the modified intention-to-treat population.
BDI, baseline dyspnoea index; BMI, body mass index; BODE index, body mass index, obstruction, dyspnoea, exercise; CCV, cardio- or cerebrovascular; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; ICS, inhaled corticosteroid; SGRQ, St George's Respiratory Questionnaire.