Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (LAC)

• Adverse event (AE) recording [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
  Number of patients to experience a Treatment Emergent Adverse Event (TEAE)
• Vital Signs [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
  Number of patients to experience a potentially clinically significant (PCS) change in pulse rate, systolic and diastolic blood pressure, body temperature or body weight.
• Electrocardiograms (ECGs) [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
  Number of patients to experience potentially clinically significant changes in ECG from Baseline.
• Clinical Laboratory Measures [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
  Number of patients to experience a potentially clinically significant (PCS) change in clinical laboratory values for Hematology, Chemistry, Urinalysis or Theophylline.

• Adverse event (AE) recording [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
  Number of patients to experience a Treatment Emergant Adverse Event (TEAE)
• Vital Signs [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
  Number of patients to experience a potentially clinically significant (PCS) change in pulse rate, systolic and diastolic blood pressure, body temperature or body weight.
• Electrocardiograms (ECGs) [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
  Number of patients to experience potentially clinically significant changes in ECG from Baseline.
• Clinical Laboratory Measures [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
  Number of patients to experience a potentially clinically significant (PCS) change in clinical laboratory values for Hematology, Chemistry, Urinalysis or Theophylline.

The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).

• Drug: Aclidinium Bromide/Formoterol Fumarate
  Inhaled Aclidinium/formoterol high dose twice per day
• Drug: Formoterol Fumarate
  Inhaled Formoterol 12 μg, twice per day

• Experimental: 1
  Aclidinium/formoterol FDC, high dose twice per day
  Intervention: Drug: Aclidinium Bromide/Formoterol Fumarate
• Active Comparator: 2
  Formoterol 12 μg
  Intervention: Drug: Formoterol Fumarate

Inclusion Criteria:

• Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
• A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.

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