Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD

Inclusion Criteria

• Twenty-four patients with physician-diagnosed COPD (female and male, current smokers or ex-smokers) over the age of 45 years will be recruited for this study.
• The patients will have to have a smoking history of at least 10 pack-years, and they must have been using an ICS regularly for at least 4 weeks at the time of screening.
• Confirmation of the diagnosis of COPD will require the presence of persistent exertional dyspnea and a post-bronchodilator FEV1 of less than 80% of predicted and FEV1/FVC ratio less than 0.7 (GOLD stage ≥2). At entry into the study, the patients will have to be clinically stable; they will be allowed to remain on their regular COPD treatment regimen and use a LABA and/or LAMA until 24 hours before, and a SABA and/or short-acting muscarinic antagonist (SAMA) until 6 hours before coming to the laboratory. If using roflumilast, the subjects will have to discontinue it 4 weeks before entering into the study.-

Exclusion Criteria

• Women of childbearing potential who do not use accepted birth control measures
• Pregnant and breast-feeding women.
• Use of cardiovascular medications that cannot be held on the study days
• Use of oral airway medications or anti-inflammatory agents
• Use of supplemental oxygen that cannot be discontinued during the laboratory visit
• Subjects with known SABA or roflumilast intolerance
• An acute COPD exacerbation within four weeks prior to the study