Evaluar en la EPOC estable el efecto de la simvastatina sobre: (1) la función endotelial
Conditions
Interventions
Trade Name: Simvastatin
Pharmaceutical Form: Capsule*
INN or Proposed INN: SIMVASTATIN
CAS Number: 79902639
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Phar
Sponsors
Hospital Son Dureta
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male former smokers with moderate to severe (FEV1 between 30 and 80% predicted post-bronchodilation) stable COPD (GOLD II-III) with 40-80 years of age. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To be diagnosed of chronic diseases different to chronic obstructive pulmonary disease (COPD) (neoplasm, chronic pain, liver diseases, kidney diseases, bronchial asthma, hypertension, any acute or chronic vascular disease, diabetes, or diabetes, etc), regular use of some medications (statins, vasodilators, hypnotics...), any drug abuse including alcoholism, oral or parenteral corticosteroids and non-steroidal anti-inflammatory drugs during the lasts 4 weeks or to increase FEV1 more than 200 mL and 12% after the administration of inhaled bronchodilators).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study in patients with stable COPD the efficacy of statins (simvastatin) on endothelial function evaluated by vascular reactivity and number of circulating endothelial progenitor cells. ;Secondary Objective: To evaluate in patients with stable COPD the efficacy of statins on: (1) pulmonary and systemic inflammation; and (2) BODE (B: body mass index, O: bronchial obstruction, D: dyspnea and, E: exercise tolerance) index. ;Primary end point(s): Biological variables: (1) markers of endothelial function: circulating endothelial progenitor cells, expression of soluble adhesion molecules and assessment of systemic vascular reactivity; (2) pulmonary inflammation: exhaled nitric oxide, cytokines (IL) 1, 6, 8, antioxidant capacity and oxidative stress in sputum; (3) systemic inflammation: C reactive protein (CRP), antioxidant capacity and oxidative stress, IL- 1, 6, 8 in plasma. | — |
Countries
Spain
Outcome results
None listed