Efficacy of Simvastatin for the Treatment of COPD
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ClinicalTrials.gov Identifier: NCT02070133 |
Recruitment Status
:
Completed
First Posted
: February 25, 2014
Last Update Posted
: February 25, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease | Drug: Simvastatin Drug: Placebo | Phase 3 |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070133
Spain | |
Fundacio Caubet-CIMERA | |
Bunyola, Illes Balears, Spain, 07110 | |
Hospital Son Espases | |
Palma Mallorca, Illes Balears, Spain, 07010 |
Principal Investigator: | Ernest Sala, MD | Hospital Son Espases, Palma Mallorca |
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 Key Record Dates |
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 |