Safety and Efficacy of NVA237 as an add-on to Fixed Dose Combination LABA/ICS

Exclusion Criteria

• •Pregnant or nursing (lactating) women
• •Women of child-bearing potential, unless they are using effective methods of contraception during the study
• •Patients with a history of long QT syndrome or whose QTc measured at run-in (Visit 2) (Fridericia method) is prolonged (\>450 ms). (These patients cannot be re-screened.)
• •Patients with evidence (upon visual inspection) of oropharyngeal candidiasis at baseline with or without treatment.
• •Patients who have not achieved an acceptable spirometry result at run-in (Visit 2) in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria for acceptability and repeatability.
• •Patients who have had a COPD exacerbation that required treatment with antibiotics or oral corticosteroids or hospitalization in the 6 weeks prior to screening (Visit 1).
• •Patients who have had a respiratory tract infection within 4 weeks prior to screening (Visit 1).
• •Patients requiring long term oxygen therapy prescribed for \>12 hours per day.
• •Patients with allergic rhinitis who use an H1 antagonist or intra-nasal corticosteroids intermittently. (Treatment with a stable dose or regimen is permitted.)
• •Patients with concomitant pulmonary disease (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, or pulmonary hypertension), clinically significant bronchiectasis, or history of pulmonary lobectomy, lung volume reduction surgery, or lung transplantation.
• •Patients with active pulmonary tuberculosis, unless confirmed by imaging to be no longer active.