Efficacy of Simvastatin for the Treatment of COPD

Phase 3CompletedNCT02070133

Hospital Universitari Son Dureta18 enrolled

Overview

To evaluate in patients with stable Chronic Obstructive Pulmonary Disease (COPD) the efficacy of statins (simvastatin) on: (1) endothelial function; (2) systemic inflammation; (3)BODE (B: body mass , O: bronchial obstruction, D: dyspnea and, E: exercise tolerance) index; (4) Uric acid; and, (5)vascular growth factors. Design: a 12 weeks randomized (1:1), double-blind, placebo control study. Population: 18 males with stable COPD between 40-80 years of age, exsmokers, with Forced expiratory volume in one second (FEV1) between 30 and 80% predicted post-bronchodilation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

SimvastatinDRUG

Simvastatin 40 mg once a day during 12 weeks

PlaceboDRUG

Placebo once a day during 12 weeks

Eligibility

Sex: MALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stable COPD between 40-80 years of age, exsmokers, with FEV1 lower that 80% predicted post-bronchodilation. Exclusion Criteria: * Severe co-morbidity (advanced-stage cancer, tuberculosis affecting more than a third of the total lung parenchyma, pneumonectomy, pneumoconiosis, left cardiac failure previously reported, known cardiopathy with ventricular dysfunction (ejection fraction \< 45%) or any cardiovascular disease, Diabetes Mellitus treated with insulin, Hypercholesterolemia, Chronic inflammatory diseases (asthma, rheumatoid arthritis, lung fibrosis, autoimmune diseases), Treatment with systemic steroid, non steroidal anti-inflammatory drugs or stains within 3 months prior to inclusion.

Locations (2)

Fundacio Caubet-CIMERA

Bunyola, Balearic Islands, Spain

Hospital Son Espases

Palma Mallorca, Balearic Islands, Spain