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
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
The purpose of this study is to evaluate the safety and efficacy of inhaled formoterol
 fumarate (7.2 and 9.6 µg ex-actuator) compared to placebo and Foradil Aerolizer in patients
 with moderate to very severe chronic obstructive pulmonary disease (COPD).
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