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Efficacy of Simvastatin for the Treatment of COPD
This study has been completed.
Sponsor:
Hospital Universitari Son Dureta
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
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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 (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:
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
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02070133
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 August 22, 2017