Placebo | Aclidinium 200 μg b.i.d. | Aclidinium 400 μg b.i.d. | Total | |
Subjects n | 273 | 277 | 269 | 819 |
Age yrs | 62.0±8.0 | 62.3±7.8 | 62.9±8.4 | 62.4±8.0 |
Males % | 69.2 | 65.3 | 67.7 | 67.4 |
Caucasians % | 95.2 | 95.0 | 95.5 | 95.2 |
COPD severity % | ||||
Moderate (GOLD II) | 65.9 | 69.6 | 68.7 | 68.1 |
Severe (GOLD III) | 34.1 | 30.4 | 31.3 | 31.9 |
Current smoker % | 52.8 | 50.5 | 55.0 | 52.8 |
Smoking history pack-yrs | 38.9±18.3 | 40.0±19.8 | 41.7±21.1 | 40.2±19.8 |
Baseline FEV1 L | 1.50±0.49 | 1.51±0.50 | 1.51±0.53 | 1.51±0.50 |
Baseline FEV1 % pred | 52.4±14.4 | 53.0±14.1 | 52.0±13.9 | 52.5±14.1 |
Post-salbutamol FEV1 % pred | 56.6±12.8 | 57.6±13.2 | 56.2±12.2 | 56.8±12.8 |
SGRQ total score | 45.1±15.8 | 46.3±16.8 | 47.6±17.7 | 46.3±16.8 |
BDI focal score | 6.7±2.0 | 7.0±2.2 | 6.7±2.1 | 6.8±2.1 |
Daily use (puffs) of salbutamol | 3.8±4.3 | 3.3±3.2 | 3.5±3.0 | 3.5±3.5 |
Pre-study COPD medication % | 91.9 | 89.5 | 88.1 | 89.9 |
ICS | 42.1 | 35.0 | 37.2 | 38.1 |
LABA | 33.0 | 27.8 | 30.1 | 30.3 |
LABA+ICS | 15.4 | 13.4 | 14.1 | 14.3 |
LAMA | 21.2 | 31.0 | 28.6 | 27.0 |
SABA | 50.2 | 48.7 | 52.4 | 50.4 |
SABA+SAMA | 9.5 | 11.6 | 11.2 | 10.7 |
SAMA | 16.5 | 16.2 | 15.2 | 16.0 |
Xanthines | 21.6 | 22.4 | 18.6 | 20.9 |
Others# | 4.0 | 4.3 | 4.8 | 4.4 |
Patients with ≥1 self-reported COPD exacerbation in previous year % | 32.6 | 35.4 | 36.2 | 34.7 |
Data are presented as mean±sd, unless otherwise stated. COPD: chronic obstructive pulmonary disease; GOLD: Global Initiative for Chronic Obstructive Lung Disease; FEV1: forced expiratory volume in 1 s; % pred: % predicted; SGRQ: St George's Respiratory Questionnaire; BDI: Baseline Dyspnoea Index; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist; SABA: short-acting β2-agonist; SAMA: short-acting muscarinic antagonist. #: systemic corticosteroids, influenza vaccine, oxygen, leukotrienes or SABA+ICS.