Efficacy of Simvastatin for the Treatment of COPD

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02070133

Enrollment

Registered

2014-02-25

Start date

2009-05-31

Completion date

2013-05-31

Last updated

2014-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Bronchitis, Statins, Endothelial dysfunction, Systemic inflammation, BODE index, Uric acid, Vascular growth factors

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.

Interventions

DRUGSimvastatin

Simvastatin 40 mg once a day during 12 weeks

DRUGPlacebo

Placebo once a day during 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

40 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
Endothelial Dysfunction (Arterial Stiffness)	Day 1 and day 84 (end of of week 12)

Secondary

Measure	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)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026