Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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