Chronic Obstructive Pulmonary Disease (COPD) Post-hospitalization Study

Inclusion Criteria

Subjects eligible for enrolment in this study must meet all of the following criteria:

• Male or female of at least 40 years of age at screening.

To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control starting on the day of visit 1, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days), as defined by any one of the following:

• Abstinence Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse
• Oral contraceptive (either combined estrogen/progestin or progestin only)
• Injectable progestogen
• Implants of levonorgestrel or etonogestrel
• Percutaneous contraceptive patches
• Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year,
• Male partner who is sterile (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or
• Double-barrier method; condom or occlusive cap (diaphragm or cervical /vault caps) plus spermicide.
• Current or former smokers with a >10 pack-year cigarette smoking history [number of pack years = (number of cigarettes per day / 20) X number of years smoked (e.g., 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]. Former smokers are defined as those who have quit smoking for at least 3 months prior to the screening visit.
• Any of the following populations:
• Patients hospitalized for a duration not exceeding 10 days due to an acute exacerbation of COPD, and who must be randomized within 10 days post-discharge.
• Patients with COPD who were treated and held for observation in the emergency department (i.e. emergency room, ER) for at least 24 hours due to an acute exacerbation of COPD, and who must be randomized within 10 days post-discharge.
• Patients who received oral corticosteroids or oral corticosteroids and antibiotics for treatment of an exacerbation of COPD during a physician's office visit and who must be randomized within 10 days of the visit, and who have been hospitalized within the previous six months due to an acute exacerbation of COPD.
• Clinical diagnosis of COPD (for at least 6 months). The following definition of COPD from the American Thoracic Society (ATS) will be used: COPD is a disease state characterized by the presence of airflow obstruction due to chronic bronchitis or emphysema; the airflow obstruction is generally progressive, may be accompanied by airway hyper-reactivity, and may be partially reversible [American Thoracic Society, 1995].
• Documented evidence (within a year prior to Visit 1) in the medical chart of spirometry confirming the diagnosis of COPD and/or spirometry performed prior to randomization (Visit 2) that confirms pre-bronchodilator FEV1/FVC ratio less than or equal to 0.70 and pre-bronchodilator FEV1 <70% of predicted.
• Review and subject's completion of written informed consent: a subject-signed and dated written informed consent (form) must be obtained prior to any study procedure, and the subject must be willing to comply with all the requirements of the study protocol.
• Subject must be able to read, comprehend, and record information in English or Spanish.

Exclusion Criteria

• Subjects meeting any of the following criteria must not be enrolled in the study:
• Diagnosis of pneumonia, congestive heart failure (CHF), or other complicating co-morbid condition while hospitalized within the last 6 months for an exacerbation of COPD.
• Historical or current evidence of clinically significant uncontrolled disease including, but not limited to, those listed below. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subjects at risk through study partici