Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease
Current and former smokers \>20 cigarettes pack-yr (if former smokers withdrawn \>1 year)
Diagnosis COPD (GOLD criteria1 for more than a year before V0)
Presence of chronic bronchitis (cough and/or expectoration for more that 3 months/yr for more than 2 consecutive yrs. in the absence of other potential cause)
Post-bronchodilator FEV1\<70% reference
Presence of established CVD, CVD equivalent or diabetes mellitus
Presence of chronic systemic inflammation, determined on:
Episode of COPD exacerbation and/or COPD treatment change during the last 2 months before V0
History of asthma, significant residual lung lesions or bronchiectasis on chest x-ray
Apnea-hypopnea syndrome
Poorly controlled CVD risk factors (Table 2) and/or change in their treatment during the last 3 months before V0
Clinically significant cardiac arrhythmias or valve disease
Severe concomitant immunological, inflammatory, infectious or neoplastic diseases
Moderate or severe hepatic insufficiency (B or C class, following Child-Pugh scale)
Severe neurologic and/or psychiatric disorder, including depression with suicidal ideas
Alcohol and/or drug abuse during the last 12 months before V0
Hypersensitivity to roflumilast or to any of its excipients
Pregnancy or potential pregnancy
Participation in other clinical trial during the last 30 days before V0
Language difficulties to follow the instructions of the study
Clareo Health | Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease
