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

NCT ID: NCT01595750

Last Updated: 2012-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-08-31

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 500 mcg , 12 weeks of treatment

Roflumilast

Roflumilast 500 mcg

Group Type: ACTIVE_COMPARATOR

Roflumilast 500

Intervention Type: DRUG

Roflumilast 500 mcg , 12 weeks of treatment

Interventions

Roflumilast 500

Roflumilast 500 mcg , 12 weeks of treatment

Intervention Type: DRUG

Placebo

Placebo 500 mcg , 12 weeks of treatment

Intervention Type: DRUG

Eligibility Criteria

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20 cigarettes pack-yr (if former smokers withdrawn 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Research Center for Respiratory Diseases

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julio Ancochea

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Princesa

Carlos Álvarez

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Doce de Octubre

Pilar De Lucas

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario Gregorio Marañón

Myriam Calle

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario San Carlos

Salvador Díaz

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramón y Cajal

Francisco García

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Rosa Malo

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Puerta de Hierro

Germán Peces-Barba

Role: PRINCIPAL_INVESTIGATOR

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Locations

Spanish Research Center for Respiratory Diseases

Bunyola, Balearic Island, Spain

Countries

Spain

Central Contacts

Àlvar Agustí

Role: CONTACT

info@ciberes.org

971 011 772

Paloma Vaquer

Role: CONTACT

pvaquer@ciberes.org

971 011 772

Facility Contacts

Paloma Vaquer

Role: primary

pvaquer@ciberes.org

0034971011772

Other Identifiers

2011-005047-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CIB-ROF-2011-01

Identifier Type: -

Identifier Source: org_study_id