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Efficacy of Simvastatin for the Treatment of COPD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02070133
First Posted: February 25, 2014
Last Update Posted: February 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fundació d'investigació Sanitària de les Illes Balears
Cimera
Information provided by (Responsible Party):
Ernest Sala, Hospital Son Espases
  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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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


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
First Submitted: October 14, 2013
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