A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation

Fecha de inicio: 1 de octubre de 2012

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 antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1. 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 with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety Other protocol defined inclusion/exclusion criteria may apply