Safety and tolerability of aclidinium bromide/formoterol fumarate compared with formoterol fumarate in patients with moderate to severe chronic obstructive pulmonary disease

Exclusion Criteria

• - Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1
• - Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1.
• - Patients with any clinically significant respiratory conditions other than COPD
• - Clinical history that suggests that the patient has asthma as opposed to COPD
• - Chronic use of oxygen therapy ≥ 15 hours/day
• - Patients with clinically significant cardiovascular conditions
• - Patients with uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis
• - Patients with a history of hypersensitivity reaction to inhaled anticholinergics,
• - Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above
• - Current diagnosis of cancer other than basal or squamous cell skin cancer