Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)

Exclusion Criteria

• - Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study
• - Current diagnosis of asthma or alpha-1 antitrypsin deficiency
• - Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea
• - Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period
• - Poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the Screening Period
• - Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period
• - Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment.
• - Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months
• - Congestive heart failure (CHF) New York Heart Association (NYHA) Class III/IV)
• - Clinically significant abnormal 12-lead ECG
• - Abnormal liver function tests defined as aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin ≥ 1.5 times upper limit of normal at Visit 1 and on repeat testing
• - Cancer not in complete remission for at least five years
• - History of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI
• Other protocol-defined inclusion/exclusion criteria may apply