Summary:
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You might be able to help us with the EMPHASIS clinical research study. If you or someone you know:
- Has emphysema/COPD
- Is between ages 40 and 75
People taking part in the study will receive study-related health care at no cost.
We hope the EMPHASIS study will help us discover whether the investigational medication has any effect on the breathing of people with emphysema, on how efficiently their lungs work and on other effects of the disease, such as coughing.
Inclusion Criteria:
- Be male or female, 40-75 yrs old, inclusive
- Rating of greater than or equal to 1 on the Goddard scale in assessment of emphysema severity by HRCT
- At least 1 documented COPD exacerbation within the past year but not within 8 weeks of study randomization
- Current or former smokers with a cigarette smoking history of at least 20 pack-years (or equivalent) and whose smoking status has not changed 60 days prior to screening
Exclusion Criteria
- Patients with asthma, active tuberculosis or bronchiectasis
- A respiratory tract infection within 30 days prior to the screening visit
- Any malignancy within 30 days prior to the screening visit
- Any malignancy within the last 5 years with the exception of non-melanomatous skin cancer
- Uncontrolled cardiovascular, endocrine, blood or nervous system disorders
- Uncontrolled condition with COPD exacerbation of level 2 or 3 in the 8-week period prior to randomization
- Systemic use of corticosteroids or other immunosuppressive agents within 30 days of the screening visit
- Subjects taking anticoagulants