Efficacy and Safety of Two Doses of Formoterol Fumarate MDI (PT005) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), Compared to Foradil® Aerolizer® as an Active Control

Key Inclusion Criteria:

- Signed written informed consent

- 40 - 80 years of age

- Fluency in written and spoken English

- Females of non-child bearing potential or females of child bearing potential with
negative pregnancy test; and acceptable contraceptive methods

- Current/former smokers with at least a 10 pack-year history of cigarette smoking

- A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70

- A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of
predicted normal values

- Competent at using the inhalation device

Key Exclusion Criteria:

- Women who are pregnant or lactating

- Primary diagnosis of asthma

- Alpha-1 antitrypsin deficiency as the cause of COPD

- Active pulmonary diseases

- Prior lung volume reduction surgery

- Abnormal chest X-ray (or CT scan) not due to the presence of COPD

- Hospitalized due to poorly controlled COPD within 12 weeks of Screening

- Poorly controlled COPD, defined as the occurrence of acute worsening of COPD
requiring corticosteroids or antibiotics or acute worsening of COPD requiring
treatment prescribed by a physician within 6 weeks of screening or between screening
and visit 2

- Lower respiratory tract infection requiring antibiotics within 6 weeks of screening

- Clinically significant medical conditions that preclude participation in the study
(e.g. clinically significant abnormal ECG or uncontrolled hypertension)

- Positive Hepatitis B surface antigen or Hepatitis C antibody

- Cancer that has not been in complete remission for at least 5 years

- History of hypersensitivity to any beta2-agonists or any study drug component

- History of severe milk protein allergy

- Known or suspected history of alcohol or drug abuse

- Medically unable to withhold short acting bronchodilators for 8-hours

- Use of prohibited medications prior to screening and during the study as specified
in the protocol

- Receiving long-term-oxygen or nocturnal oxygen therapy for >12 hours a day

- Participation in acute phase of pulmonary rehabilitation within 4 weeks of screening
or will enter acute phase of pulmonary rehabilitation program during study

- Unable to comply with study procedures

- Prior participation in a Pearl PT005 study

- Requires use of a spacer due to poor hand-to-breath coordination