Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.

Inclusion criteria

• Males and non-pregnant, non-lactating females aged ≥ 40.
• Patients with a clinical diagnosis of stable moderate to severe COPD, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines: (http://www.goldcopd.com) and stable airway obstruction. Post-salbutamol FEV1/FVC < 70% at Screening Visit (Visit 1) (i.e., 100xpost-salbutamol FEV1/FVC <70%).
• Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.
• Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post inhalation of salbutamol is 30% < FEV1 <80% of the predicted normal value (i.e., 100 x Post-salbutamol FEV1/ Predicted FEV1 must be < 80% and ≥ 30%).
• Female patients at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically approved and highly effective method of contraception.
• Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent.

Exclusion criteria

• History or current diagnosis of asthma.
• Clinically significant respiratory conditions other than COPD at the time of Inform Consent signature
• Hospitalisation due to COPD exacerbation within the previous 3 months.
• Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks.
• Clinically significant cardiovascular conditions
• Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.
• Presence of narrow-angle glaucoma.
• QTcB) above 470 milliseconds in the ECG performed at Screening Visit,
• Patient who does not maintain regular day/night, waking/sleeping cycles