Efficacy of Simvastatin for the Treatment of COPD

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Placebo; Drug: Simvastatin

• Registration Number: NCT02070133
• Lead Sponsor: Hospital Universitari Son Dureta

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2013-03
• Study Completion: 2013-05
• Study First Submitted: 2013-10-14
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-21
• Last Update Submitted: 2014-02-21
• Study First Posted: 2014-02-25
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients with COPD will receive placebo once a day during 12 weeks
Simvastatin	Simvastatin	Patients with COPD will receive simvastatin 40 mg once a day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Endothelial Dysfunction (Arterial Stiffness)	Day 1 and day 84 (end of of week 12)

Secondary Outcome Measures

Name	Time	Method
Systemic inflammation	Day 1 and day 84 (end of of week 12)
BODE index	Day 1 and day 84 (end of of week 12)
Uric acid	Day 1 and day 84 (end of of week 12)
Vascular growth factors	Day 1 and day 84 (end of of week 12)

Trial Locations

Locations (2)

Fundacio Caubet-CIMERA; 🇪🇸 Bunyola, Illes Balears, Spain

Hospital Son Espases; 🇪🇸 Palma Mallorca, Illes Balears, Spain