Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD

Inclusion criteria

• Give their signed written informed consent to participate.
• Are at least 40 years of age and no older than 80 at Visit 1.
• A female of non-child bearing potential or child bearing potential, has a negative serum pregnancy test, and agrees to approved contraceptive methods.
• COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society(ATS)/European Respiratory Society (ERS).
• Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
• FEV1/FVC ratio of <0.70.
• Post-bronchodilator FEV1 must be ≥ 30% and <80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations, and must also be greater than or equal to 750 mL.
• Subject is willing and, in the opinion of the Investigator, able to adjust current COPD therapy as required by the protocol.

Exclusion criteria

• Pregnancy, nursing females or subjects trying to conceive.
• Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study.
• Current primary diagnosis of asthma.
• History of ECG abnormalities.
• Poorly controlled or worsening COPD prior to Screening or during the Screening Period.
• Clinically significant bladder neck obstruction or urinary retention.
• Male subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening.
• Cancer that has not been in complete remission for at least five years.
• Inadequately treated glaucoma.
• History of allergic reaction or hypersensitivity to any component of the formulations used in this study.