A Multi-center, Randomized, Double-blind, 52-week Study to Assess the Safety of NVA237 Compared to QAB149 in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Have Moderate to Severe Airflow Limitation

Date de début de l'étude : 1 octobre 2012

Inclusion Criteria: Male or female patients with COPD according to GOLD 2011 who have signed informed consent. Patients with airflow limitation of 30-80% post-bronchodilator FEV1 at run-in. Current or ex-smokers with a smoking history of at least 10 pack years Patients with a mMRC score of at least 2 at run-in. Exclusion Criteria: Patients contraindicated for muscarinic antagonist agents and beta-2 agonists Patients with a history of malignancy of any organ system, treated or untreated, within the last five years Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention Patients who had a COPD exacerbation within 6 weeks prior to screening. Patients requiring long term oxygen therapy prescribed for more than 12 hr per day. Patients with a history of asthma. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to 40 years of age. Patients with a blood eosinophil count of greater than 600 mm/3 during run-in Patients with concomitant pulmonary disease Patients with a history of certain cardiovascular co-morbid conditions Patients with a diagnosis of alpha-1 anti-trypsin deficiency Patients with active pulmonary tuberculosis Patients in the active phase of a pulmonary rehabilitation programme Other protocol-defined inclusion / exclusion criteria may apply