TABLE 1.
Demographic and baseline characteristics (intention-to-treat population)
| Patients | 4324 |
| Age years | 64.6±8.30 |
| Male | 2908 (67.3) |
| Body mass index kg·m−2 | 27.6±5.00 |
| Current smokers | 2292 (53.0) |
| Duration of COPD years | 6.1±5.50 |
| mMRC grade | |
| 1 | 2591 (59.9) |
| ≥2 | 1693 (39.2) |
| BDI total score | 7.3±1.80 |
| CAT total score | 13.2±6.50 |
| CCQ total score | 1.8±0.90 |
| Post-bronchodilator FEV1 L | 1.85±0.49 |
| Post-bronchodilator FEV1 % pred | 64.7±8.70 |
| Post-bronchodilator FEV1/FVC | 0.57±0.08 |
| Exacerbations in previous 12 months | |
| 1 | 867 (20.1) |
| ≥2 | 16 (0.4) |
| Baseline treatment | |
| SABA, SAMA or SABA+SAMA | 496 (11.5) |
| LABA+ICS (fixed-dose or free combination) | 1059 (24.5) |
| LABA (only monotherapy) | 1193 (27.6) |
| LAMA (only monotherapy) | 1512 (35.0) |
| Others/not applicable/unknown# | 187 (4.4) |
Data are presented as n, mean±sd or n (%). COPD: chronic obstructive pulmonary disease; mMRC: modified Medical Research Council dyspnoea scale; BDI: Baseline Dyspnoea Index; CAT: COPD Assessment Test; CCQ: Clinical COPD Questionnaire; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; SABA: short-acting β2-agonist; SAMA: short-acting muscarinic antagonist; LABA: long-acting β2-agonist; ICS: inhaled corticosteroid; LAMA: long-acting muscarinic antagonist. #: LAMA+ICS, LABA+LAMA, ICS monotherapy, LABA+LAMA+ICS (triple), systemic corticosteroids, methylxanthines, roflumilast and others.