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.