Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)

A randomized, double-blind, multi-center, parallel-group study to assess the efficacy and
safety of PT010 relative to PT003 and PT009 on COPD exacerbations over a 52-week treatment
period in subjects with moderate to very severe COPD.

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 (FEV1)/Forced vital capacity (FVC) ratio must be
<0.70 and FEV1 must be <65% predicted normal value calculated using NHANES III
reference equations (or reference norms applicable to other regions).

- Subjects with history of exacerbations.

Please refer to the study protocol for the complete inclusion criteria list.

Exclusion Criteria

- Significant diseases or conditions other than COPD, 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 are planning to become pregnant during the
course of the study, 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)

- 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)

- Immune suppression or severe neurological disorders affecting control of the upper
airway or other risk factors that in the opinion of the Investigator would put the
subject at substantial risk of pneumonia.

- Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the
Investigator, have not been adequately treated.

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

Please refer to the study protocol for the complete inclusion criteria list.