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

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