Baseline demographics and clinical characteristics
| QVA149 (110/50 µg) (N=476) | TIO (18 µg)+FOR (12 µg) (N=458) | Total (N=934) | |
|---|---|---|---|
| Age, years | 62.6 (8.4) | 63.1 (8.2) | 62.9 (8.3) |
| Gender, n (%) | |||
| Male | 317 (66.6) | 298 (65.1) | 615 (65.8) |
| Race, n (%) | |||
| Caucasian | 472 (99.2) | 454 (99.1) | 926 (99.1) |
| Duration of COPD (years) | 6.5 (5.3) | 6.8 (5.2) | 6.6 (5.2) |
| Severity of COPD*, n (%) | |||
| Moderate | 267 (57.7) | 253 (55.7) | 520 (56.7) |
| Severe | 193 (41.7) | 195 (43.0) | 388 (42.3) |
| COPD exacerbation history, n (%) | |||
| 0 | 411 (86.3) | 396 (86.5) | 807 (86.4) |
| 1 | 60 (12.6) | 57 (12.4) | 117 (12.5) |
| ≥2 | 3 (0.6) | 4 (0.9) | 7 (0.7) |
| ICS use at baseline, n (%) | 201 (42.2) | 184 (40.2) | 385 (41.2) |
| Smoking history, n (%) | |||
| Current smokers | 234 (49.2) | 224 (48.9) | 458 (49.0) |
| Number of pack-years | 41.1 (19.1) | 41.8 (19.6) | 41.4 (19.3) |
| Pre-bronchodilator FEV1 (L) | 1.34 (0.5) | 1.31 (0.5) | 1.33 (0.5) |
| Post-bronchodilator FEV1 (L) | 1.6 (0.5) | 1.5 (0.5) | 1.6 (0.5) |
| Post-bronchodilator FEV1, % predicted | 53.3 (13.4) | 53.0 (13.2) | 53.2 (13.3) |
| Post-bronchodilator FEV1 reversibility, %† | 19.3 (18.4) | 19.6 (18.2) | 19.4 (18·3) |
| Post-bronchodilator FEV1/FVC (%) | 53.3 (10.5) | 52.1 (10.0) | 52.7 (10.3) |
| BDI | 6.5 (2.0) | 6.4 (2.1) | – |
| SGRQ-C total score | 44.7 (17.7) | 45.7 (17.7) | – |
Data are mean (SD) unless otherwise stated.
*COPD severity is based on the GOLD 2010 criteria.
†Assessed after administration of 84 µg ipratropium bromide and 400 µg salbutamol.
BDI, Baseline Dyspnoea Index; FEV1, forced expiratory volume in 1 s; FOR, formoterol; FVC, forced vital capacity; GOLD, Global Initiative for Chronic Obstructive Lung Disease; ICS, inhaled corticosteroids; Pack-years, total years of smoking multiplied by cigarette packs smoked per day; SGRQ-C, St George's Respiratory Questionnaire-COPD; TIO, tiotropium.