Efficacy of Simvastatin for the Treatment of COPD

This study has been completed.

Sponsor:

Collaborators:

Fundació d'investigació Sanitària de les Illes Balears

Cimera

Information provided by (Responsible Party):

Ernest Sala, Hospital Son Espases

ClinicalTrials.gov Identifier:

NCT02070133

First received: October 14, 2013

Last updated: February 21, 2014

Last verified: February 2014

History of Changes

Purpose

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	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Simvastatin Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
Official Title:	Pilot Study on the Efficacy of Statins for the Treatment of Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

MedlinePlus related topics: COPD Lung Diseases

Drug Information available for: Simvastatin

U.S. FDA Resources

Further study details as provided by Ernest Sala, Hospital Son Espases:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	18
Study Start Date:	May 2009
Study Completion Date:	May 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070133

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


Responsible Party:	Ernest Sala, Medical Doctor, Hospital Son Espases
ClinicalTrials.gov Identifier:	NCT02070133 History of Changes
Other Study ID Numbers:	EC08/00123
Study First Received:	October 14, 2013
Last Updated:	February 21, 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

ClinicalTrials.gov processed this record on June 23, 2017

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