Table 1.
Baseline demographics and clinical characteristics
| Characteristics | Tiotropium N=248 | SFC N=87 | IND/GLY All patients N=338* |
|---|---|---|---|
|
| |||
| Age, years | 66.6±9.0 | 64.7±10.6 | 66.1±9.5 |
| Gender – men, n (%) | 140 (56.5) | 49 (56.3) | 189 (55.9) |
| BMI, kg/m2 | 28.1±6.4 | 29.3±6.6 | 28.4±6.5 |
| Current smoker, n (%) | 123 (49.6) | 46 (52.9) | 172 (50.9) |
| Smoking history, pack years | 49.3±43.6 | 43.0±22.7 | 47.6±39.2 |
| Duration of COPD, years | 4.1±4.3 | 6.7±5.9 | 4.8±4.9 |
| Severity of airflow limitation (as per GOLD 2011), n (%) | |||
| Mild (GOLD 1) | 22 (8.9) | 10 (11.5) | 32 (9.5) |
| Moderate (GOLD 2) | 163 (65.7) | 61 (70.1) | 226 (66.9) |
| Severe (GOLD 3) | 56 (23.8) | 15 (17.2) | 75 (22.2) |
| Very severe (GOLD 4) | 4 (1.6) | 1 (1.1) | 5 (1.5) |
| Pre-dose FEV1, L | 1.662±0.570 | 1.734±0.688 | 1.678±0.603 |
| Pre-dose FEV1, % predicted of normal value | 61.3±15.42 | 64.1±16.6 | 62.0±15.8 |
| COPD exacerbations during the previous year, n (%) | |||
| 0 | 214 (86.3) | 73 (83.9) | 288 (85.2) |
| 1 | 34 (13.7) | 14 (16.1) | 50 (14.8) |
| CAT score | 18.1±6.1 | 21.1±6.9 | 18.9±6.4 |
| Baseline dyspnea index | 6.8±2.1 | 6.5±2.1 | 6.7±2.1 |
| COPD maintenance treatment | |||
| Tiotropium (LAMA) | 248 (73.4) | – | 248 (73.4) |
| SFC FDC (LABA/ICS) | – | 87 (25.7) | 87 (25.7) |
| 50/100 µg (DPI) or 50/125 µg (pMDI) | – | 9 | 9 |
| 50/250 µg (DPI) | – | 58 | 58 |
| 50/500 µg (DPI) | – | 11 | 11 |
| Unknown dose | – | 9 | 9 |
Notes: Data are presented as means ± SD, unless specified otherwise.
*
COPD maintenance treatment was missing for 3 subjects.
Abbreviations: BMI, body mass index; COPD, chronic obstructive pulmonary disease; CAT, COPD assessment test; DPI, dry powder inhaler; pMDI, pressurized metered dose inhaler; FDC, fixed dose combination; FEV1, forced expiratory volume in 1s; ICS, inhaled corticosteroid; IND/GLY, indacaterol/glycopyrronium; LABA, long-acting beta-agonist; LAMA, long-acting muscarinic antagonist; N, number of patients in each treatment group; SD, standard deviation; SFC, salmeterol/fluticasone combination.