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

Inclusion criteria

• Male and female subjects, > 40 years of age
• Clinical diagnosis of moderate to severe COPD as defined by the GOLD criteria:

Post-bronchodilator FEV1/FVC < 70% Post-bronchodilator FEV1 < 70% predicted

• Cigarette consumption of 10 pack-years or more. Patients may be active smokers.
• The presence of chronic cough and sputum production
• Willingness to make return visits and telephone availability for the study duration

Exclusion criteria

• A diagnosis of asthma as established by the study investigator on the basis of the recent American Thoracic Society/European Respiratory Society guidelines
• Clinically significant bronchiectasis
• Oxygen use >12 hours/day
• Known sensitivity to roflumilast
• Use of other methylxanthines within 1 month (theophylline)
• Changes to current maintenance COPD therapy within one month
• Pregnancy
• An acute illness requiring antibiotics and/or corticosteroids within the month prior to enrolment.
• Immunosuppression

• HIV
• Solid organ transplant
• Active malignancy
• Systemic corticosteroid use ≥ prednisone 20mg / day
• Other immunosuppressants
• Terminal illness defined as anticipated survival <12 months
• 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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