Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Pilot Study on the Efficacy of Statins for the Treatment of Chronic Obstructive Pulmonary Disease
Verified date | February 2014 |
Source | Hospital Universitari Son Dureta |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | May 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Fundacio Caubet-CIMERA | Bunyola | Illes Balears |
Spain | Hospital Son Espases | Palma Mallorca | Illes Balears |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari Son Dureta | Cimera, Fundació d'investigació Sanitària de les Illes Balears |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endothelial Dysfunction (Arterial Stiffness) | Day 1 and day 84 (end of of week 12) | No | |
Secondary | Systemic inflammation | Day 1 and day 84 (end of of week 12) | No | |
Secondary | BODE index | Day 1 and day 84 (end of of week 12) | No | |
Secondary | Uric acid | Day 1 and day 84 (end of of week 12) | No | |
Secondary | Vascular growth factors | Day 1 and day 84 (end of of week 12) | No |
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