Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation

Inclusion criteria:

• Male and female adults aged ≥40 years.

• Patients with stable COPD according to GOLD strategy (GOLD 2011).

• Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, and a post-bronchodilator.

• FEV1/FVC < 0.70.

• Current or ex-smokers who have a smoking history of at least 10 pack years.

• Patients with an mMRC ≥ grade 2

Exclusion criteria:

• History of long QT syndrome or prolonged QTc.

• Patients who have had a COPD exacerbation that required treatment with antibioticsand/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit

• Patients with Type I or uncontrolled Type II diabetes.

• Patients with a history of asthma or have concomitant pulmonary disease.

• Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients withpersistent atrial fibrillation and controlled with a rate control strategy for atleast six months could be eligible.

• Patients who have clinically significant renal, cardiovascular, neurological,endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematologicalabnormalities which could interfere with the assessment of safety.