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

NCT01595750 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-05-10

No results posted yet for this study

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

Interventions

DRUG

Roflumilast 500

Roflumilast 500 mcg , 12 weeks of treatment

DRUG

Placebo

Placebo 500 mcg , 12 weeks of treatment

Sponsors & Collaborators

  • Spanish Research Center for Respiratory Diseases

    lead OTHER

Principal Investigators

  • Julio Ancochea · Hospital Universitario La Princesa

  • Carlos Álvarez · Hospital Universitario Doce de Octubre

  • Pilar De Lucas · Hospital General Universitario Gregorio Marañón

  • Myriam Calle · Hospital Clínico Universitario San Carlos

  • Salvador Díaz · Hospital Universitario Ramón y Cajal

  • Francisco García · Hospital Universitario La Paz

  • Rosa Malo · Hospital Universitario Puerta de Hierro

  • Germán Peces-Barba · Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-07-31
Completion
2012-08-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01595750 on ClinicalTrials.gov