Estudio piloto de la eficacia de las estatinas en el tratamiento de la enfermedad pulmonar obstructiva crónica. (Pilot study on the efficacy of statins for the treatment of Chronic Obstructive Pulmonary Disease).

• Conditions: Evaluar en la EPOC estable el efecto de la simvastatina sobre: (1) la función endotelial; (2) la inflamación pulmonar y sistémica; y, (3) el índice BODE (B: masa corporal, O: obstrucción bronquial, D: disnea y, E: tolerancia al ejercicio). (To investigate the efficacy of simvastatin in patients with COPD on: (1) pulmonary and systemic inflammation; (2) endothelial function; and, (3) BODE (B: body mass index, O: bronchial obstruction, D: dyspnea and, E: exercise tolerance) index).

• Registration Number: EUCTR2007-003916-74-ES
• Lead Sponsor: Hospital Son Dureta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified