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Efficacy of Simvastatin for the Treatment of COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Simvastatin

Placebo

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Bronchitis, Statins, Endothelial dysfunction, Systemic inflammation, BODE index, Uric acid, Vascular growth factors

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

Fundacio Caubet-CIMERA
Hospital Son Espases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Simvastatin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Endothelial Dysfunction (Arterial Stiffness)

Secondary Outcome Measures

Systemic inflammation

BODE index

Uric acid

Vascular growth factors

Full Information

NCT ID

NCT02070133

First Posted

October 14, 2013

Last Updated

February 21, 2014

Sponsor

Hospital Universitari Son Dureta

Collaborators

Fundació d'investigació Sanitària de les Illes Balears, Cimera

1. Study Identification

Unique Protocol Identification Number

NCT02070133

Brief Title

Efficacy of Simvastatin for the Treatment of COPD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Universitari Son Dureta

Collaborators

Fundació d'investigació Sanitària de les Illes Balears, Cimera

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Simvastatin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Simvastatin

Intervention Description

Simvastatin 40 mg once a day during 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo once a day during 12 weeks

Primary Outcome Measure Information:

Title

Endothelial Dysfunction (Arterial Stiffness)

Time Frame