Efficacy of Simvastatin for the Treatment of COPD

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Type :	Interventional (Clinical Trial)
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 2009
Actual Primary Completion Date :	March 2013
Actual Study Completion Date :	May 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Systemic inflammation [ Time Frame: Day 1 and day 84 (end of of week 12) ]
2. BODE index [ Time Frame: Day 1 and day 84 (end of of week 12) ]
3. Uric acid [ Time Frame: Day 1 and day 84 (end of of week 12) ]
4. Vascular growth factors [ Time Frame: Day 1 and day 84 (end of of week 12) ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	40 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Spain
Fundacio Caubet-CIMERA
Bunyola, Illes Balears, Spain, 07110
Hospital Son Espases
Palma Mallorca, Illes Balears, Spain, 07010

Sponsors and Collaborators

Hospital Universitari Son Dureta

Fundació d'investigació Sanitària de les Illes Balears

Cimera

Investigators

Principal Investigator:	Ernest Sala, MD	Hospital Son Espases, Palma Mallorca

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ernest Sala, Medical Doctor, Hospital Son Espases
ClinicalTrials.gov Identifier:	NCT02070133 History of Changes
Other Study ID Numbers:	EC08/00123
First Posted:	February 25, 2014
Last Update Posted:	February 25, 2014
Last Verified:	February 2014

Keywords provided by Ernest Sala, Hospital Son Espases:

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

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Simvastatin; Anticholesteremic Agents	Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors