Efficacy of Simvastatin for the Treatment of COPD

Sponsor

Hospital Universitari Son Dureta (Other)

Overall Status

Completed

CT.gov ID

NCT02070133

Collaborator

Fundació d'investigació Sanitària de les Illes Balears (Other), Cimera (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Simvastatin Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Pilot Study on the Efficacy of Statins for the Treatment of Chronic Obstructive Pulmonary Disease

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Simvastatin Patients with COPD will receive simvastatin 40 mg once a day for 12 weeks	Drug: Simvastatin Simvastatin 40 mg once a day during 12 weeks
Placebo Comparator: Placebo Patients with COPD will receive placebo once a day during 12 weeks	Drug: Placebo Placebo once a day during 12 weeks

Arm

Intervention/Treatment

Experimental: Simvastatin

Patients with COPD will receive simvastatin 40 mg once a day for 12 weeks

Drug: Simvastatin

Simvastatin 40 mg once a day during 12 weeks

Placebo Comparator: Placebo

Patients with COPD will receive placebo once a day during 12 weeks

Drug: Placebo

Placebo once a day during 12 weeks

Outcome Measures

Primary Outcome Measures

Endothelial Dysfunction (Arterial Stiffness) [Day 1 and day 84 (end of of week 12)]

Secondary Outcome Measures

Systemic inflammation [Day 1 and day 84 (end of of week 12)]
BODE index [Day 1 and day 84 (end of of week 12)]
Uric acid [Day 1 and day 84 (end of of week 12)]
Vascular growth factors [Day 1 and day 84 (end of of week 12)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.