A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)

Exclusion Criteria

• •1. A diagnosis of asthma as established by the study investigator on the basis of the recent American Thoracic Society/European Respiratory Society guidelines
• •2. Clinically significant bronchiectasis
• •3. Oxygen use \>12 hours/day
• •4. Known sensitivity to roflumilast
• •5. Use of other methylxanthines within 1 month (theophylline)
• •6. Changes to current maintenance COPD therapy within one month
• •7. Pregnancy
• •8. An acute illness requiring antibiotics and/or corticosteroids within the month prior to enrolment.
• •9. Immunosuppression
• •1. HIV
• •2. Solid organ transplant
• •3. Active malignancy
• •4. Systemic corticosteroid use ≥ prednisone 20mg / day
• •5. Other immunosuppressants
• •10. Terminal illness defined as anticipated survival \<12 months
• •11. Severe comorbidities including uncontrolled angina, congestive heart failure, end-stage renal disease, liver failure, or other conditions that would preclude the patient from safely completing the required tests or the study.
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