Efficacy of Simvastatin for the Treatment of COPD
NCT02070133 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2014-02-25
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.
Conditions
Interventions
- DRUG
-
Simvastatin
Simvastatin 40 mg once a day during 12 weeks
- DRUG
-
Placebo once a day during 12 weeks
Sponsors & Collaborators
-
Fundació d'investigació Sanitària de les Illes Balears
collaborator OTHER_GOV -
Cimera
collaborator NETWORK -
Hospital Universitari Son Dureta
lead OTHER
Principal Investigators
-
Ernest Sala, MD · Hospital Son Espases, Palma Mallorca
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-05-31
- Primary Completion
- 2013-03-31
- Completion
- 2013-05-31
Countries
- Spain
Study Locations
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