NVA237 50 μg q.d. | Placebo | Tiotropium 18 μg q.d. | |
Subjects n | 525 | 268 | 267 |
Age yrs | 63.5±9.1 | 63.6±9.1 | 63.9±8.2 |
Sex | |||
Male | 339 (64.6) | 173 (64.6) | 168 (62.9) |
Female | 186 (35.4) | 95 (35.4) | 99 (37.1) |
Ethnicity | |||
Caucasian | 459 (87.4) | 236 (88.1) | 232 (86.9) |
Black | 20 (3.8) | 10 (3.7) | 12 (4.5) |
Asian | 26 (5.0) | 12 (4.5) | 15 (5.6) |
Other | 20 (3.8) | 10 (3.7) | 8 (3.0) |
Body mass index kg·m−2 | 27.9±6.2 | 27.5±6.2 | 27.7±6.4 |
Severity of COPD (GOLD 2008) | |||
Moderate | 332 (63.2) | 174 (64.9) | 172 (64.4) |
Severe | 187 (35.6) | 92 (34.3) | 94 (35.2) |
Very severe | 6 (1.1) | 2 (0.7) | 0 |
Duration of COPD yrs | 7.2±6.6 | 7.4±6.6 | 7.5±6.6 |
Baseline COPD exacerbation history# | |||
0 exacerbations | 377 (71.8) | 206 (76.9) | 195 (73.0) |
1 exacerbations | 113 (21.5) | 43 (16.0) | 55 (20.6) |
≥2 exacerbations | 35 (6.7) | 19 (7.1) | 17 (6.4) |
ICS use at baseline | 293 (55.8) | 137 (51.1) | 138 (51.7) |
Smoking history | |||
Ex-smoker | 287 (54.7) | 144 (53.7) | 149 (55.8) |
Current smoker | 238 (45.3) | 124 (46.3) | 118 (44.2) |
Duration of smoking pack-yrs | 49.0±25.4 | 48.0±24.0 | 50.2±28.0 |
Patients on different COPD medications prior to start of study# | |||
LAMA | 134 (25.5) | 66 (24.6) | 92 (34.5) |
LABA | 58 (11.0) | 38 (14.2) | 25 (9.4) |
SABA | 229 (43.9) | 105 (39.2) | 124 (46.4) |
SAMA | 66 (12.6) | 36 (13.4) | 33 (12.4) |
ICS+LABA | 194 (37.0) | 88 (32.8) | 97 (36.3) |
Xanthine derivatives | 32 (6.1) | 15 (5.6) | 17 (6.4) |
ICS | 13 (2.5) | 4 (1.5) | 3 (1.1) |
Leukotriene modifiers | 4 (0.8) | 7 (2.6) | 3 (1.1) |
Pre-bronchodilator FEV1 L | 1.3±0.5 | 1.4±0.5 | 1.3±0.5 |
Post-bronchodilator FEV1 L | 1.5±0.5 | 1.5±0.5 | 1.5±0.5 |
Post-bronchodilator FEV1 % pred | 55.7±13.0 | 56.4±14.0 | 56.0±13.0 |
Post-bronchodilator FEV1 reversibility % | 16.2±15.2 | 14.6±14.5 | 16.4±14.5 |
Post-bronchodilator FEV1/FVC % | 50.6±10.5 | 50.9±10.5 | 50.3±10.5 |
Data are presented as mean±sd or n (%), unless otherwise stated. COPD: chronic obstructive pulmonary disease; GOLD: Global Initiative for Chronic Obstructive Lung Disease; ICS: inhaled corticosteroid; LAMA: long-acting muscarinic antagonist; LABA: long-acting β2-agonist; SABA: short-acting β2-agonist; SAMA: short-acting muscarinic antagonist; FEV1: forced expiratory volume in 1 s; % pred: % predicted; FVC: forced vital capacity. Pack-yrs refers to the total years of smoking multiplied by cigarette packs smoked per day. COPD exacerbation history is the number of moderate or severe COPD exacerbations in the year prior to screening. Severity of COPD is classified based on per cent predicted FEV1 and FEV1/FVC post-bronchodilation at the screening visit. Per cent predicted FEV1 is obtained as a percentage of FEV1 relative to the predicted normal value. #: >1% of total patients.