Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease
Inclusion Criteria:
- Signed informed consent
- 55-75 years of age
- 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20 cigarettes pack-yr (if former smokers withdrawn 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:
1. Serum CRP ≥ 2 and < 10 mg/l or
2. Serum fibrinogen > 518 mg/dl and Leucocytes > 8,6*106 /mm3
Exclusion Criteria:
- 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