Efficacy and safety of two fixed dose combinations of aclidinium bromide with formoterol fumarate - ALIGHT-COPD

Inclusion Criteria

• 1. Adult male or non-pregnant, non-lactating female aged between 40 and 80 years old, both inclusive.
• 2. Patient with a clinical diagnosis of stable moderate to severe COPD according to the GOLD classification
• 3. Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.
• 4. 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%).
• 5. 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%).
• 6. 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.
• 7. 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