Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate

Inclusion criteria

• Adult male or non-pregnant, non-lactating female aged between 40 and 80 years old, both inclusive.
• Patient with a clinical diagnosis of stable moderate to severe COPD according to the GOLD classification
• 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 400 mcg 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%).
• Patient whose FEV1/FVC at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is < 70% (i.e., 100 x Post-salbutamol FEV1 /FVC < 70%).
• Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained.
• Patient whose COPD symptoms and FEV1 values at the time of randomisation are stable compared to the Screening Visit, according to the investigator's medical judgment

Exclusion criteria

• History or current diagnosis of asthma or exercise-induced bronchospasm.
• Clinically significant respiratory conditions 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.
• Patient who has a resting systolic blood pressure ≥ 200 mmHg, a resting diastolic blood pressure ≥ 120 mmHg or a resting heart rate ≥ 105 bpm at screening visit.
• Clinically significant cardiovascular conditions
• Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.
• Presence of narrow-angle glaucoma.
• QTc [calculated according to Bazett's formulae (QTc=QT/RR1/2) above 470 milliseconds in the ECG performed at Screening Visit,
• Patient who does not maintain regular day/night, waking/sleeping cycles