Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD

A randomized, double-blind, chronic dosing (24 weeks), placebo-controlled, parallel group,
multi-center study to assess the efficacy and safety of glycopyrronium and formoterol
fumarate inhalation aerosol (GFF; PT003), formoterol fumarate inhalation aerosol (FF; PT005),
and glycopyrronium inhalation aerosol (GP; PT001) in subjects with moderate to very severe
COPD, compared with placebo.

Inclusion Criteria:

- Non-child bearing potential (ie, physiologically incapable of becoming pregnant,
including any female who is 2 years post-menopausal); or Child bearing potential, has
a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive
methods used consistently and correctly for the duration of the study.

- 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.

- Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of <0.70.

- FEV1 must be <80% predicted normal value calculated using the Third National Health
and Nutrition Examination Survey (NHANES III) reference equations. (Or reference norms
applicable to other regions).

Exclusion Criteria:

- Significant diseases other than COPD, ie, disease or condition which, in the opinion
of the Investigator, may put the subject 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.

- Women who are pregnant or lactating or women of childbearing potential who are not
using an acceptable method of contraception.

- Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.

- Subjects who have been hospitalized due to poorly controlled COPD within 3 months
prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).

- Subjects who have poorly controlled COPD, defined as acute worsening of COPD that
requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to
Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).

- Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of
whether or not they have been treated. Subjects with a diagnosis of open angle
glaucoma who have intraocular pressure controlled with medication(s) are eligible.

- Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or
other muscarinic anticholinergics, or any component of the MDI.