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

Sponsor
Spanish Research Center for Respiratory Diseases
Study ID
NCT01595750
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast 500 — DRUG
    Roflumilast 500 mcg , 12 weeks of treatment
  • Placebo — DRUG
    Placebo 500 mcg , 12 weeks of treatment

Study Details

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.

Key Dates

Start date
May 31, 2012
Status verified
May 2012
Primary completion
Jul 31, 2012
Completion
Aug 31, 2012

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
  • Active Comparator: Roflumilast
    Roflumilast 500 mcg

Primary Outcome Measure

Endotelial function [ Time Frame: 12 weeks ]

Central Contacts

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