Efficacy of Simvastatin for the Treatment of COPD

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Simvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvastatin<br>Patients with COPD will receive simvastatin 40 mg once a day for 12 weeks | Drug: Simvastatin<br>* Simvastatin 40 mg once a day during 12 weeks<br>|
| Placebo Comparator: Placebo<br>Patients with COPD will receive placebo once a day during 12 weeks | Drug: Placebo<br>* Placebo once a day during 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Dysfunction (Arterial Stiffness) |  | Day 1 and day 84 (end of of week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uric acid, Vascular growth factors, Systemic inflammation, BODE index, Chronic Bronchitis, Statins, Endothelial dysfunction