Trial | NCT02070133  Report issue

Title

Efficacy of Simvastatin for the Treatment of COPD
Pilot Study on the Efficacy of Statins for the Treatment of Chronic Obstructive Pulmonary Disease

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    simvastatin ...

  • Study Participants

    18
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.
Study Started
May 31
2009
Primary Completion
Mar 31
2013
Study Completion
May 31
2013
Last Update
Feb 25
2014
Estimate

Drug Simvastatin

Simvastatin 40 mg once a day during 12 weeks

Drug Placebo

Placebo once a day during 12 weeks

Simvastatin Experimental

Patients with COPD will receive simvastatin 40 mg once a day for 12 weeks

Placebo Placebo Comparator

Patients with COPD will receive placebo once a day during 12 weeks

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.
No Results Posted