Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease (REVASC)

Spanish Research Center for Respiratory Diseases

Status and phase

Unknown

Phase 4

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Placebo

Drug: Roflumilast 500

Study type

Interventional

Funder types

Other

Identifiers

NCT01595750

2011-005047-27 (EudraCT Number)

CIB-ROF-2011-01

Details and patient eligibility

About

REVASC is a randomized, double-blind, placebo-controlled study which will involve 150 patients with chronic bronchitis and COPD diagnosed cardiovascular disease. The recruitment period beginimg in the coming weeks, will last nine months. Patients included in the study will receive treatment for three months with roflumilast 500 mg (75 patients) or placebo (75 patients) in a randomized manner. The CIBERES, as promoter of this study is expected to release final results for the third quarter of 2013.

Eight centers in Madrid will be involved in this clinical trial: Fundación Jiménez Díaz, Hospital La Princesa, Hospital Gregorio Maranon Hospital Clinico San Carlos, Hospital La Paz, Hospital Ramón y Cajal Hospital Doce de Octubre and Hospital Puerta del Hierro.

Roflumilast is a potent phosphodiesterase-4 inhibitor (PDE4). Its clinical efficacy has been studied in an extensive clinical program involving over 12,000 patients with COPD. In these studies, roflumilast (in combination with long-acting bronchodilators) reduced the number of exacerbations and improved lung function, especially in those patients with associated chronic bronchitis.

Enrollment

150 estimated patients

Sex

All

Ages

55 to 75 years old

Volunteers

No Healthy Volunteers

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20 cigarettes pack-yr (if former smokers withdrawn 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