Efficacy of Simvastatin for the Treatment of COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070133
• Other study ID #: EC08/00123
• Status: Completed
• Phase: Phase 3
• First received: October 14, 2013
• Last updated: February 21, 2014
• Start date: May 2009
• Est. completion date: May 2013

Study information

• Verified date: February 2014
• Source: Hospital Universitari Son Dureta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Simvastatin
Simvastatin 40 mg once a day during 12 weeks
• Placebo
Placebo once a day during 12 weeks

Locations

Country	Name	City	State
Spain	Fundacio Caubet-CIMERA	Bunyola	Illes Balears
Spain	Hospital Son Espases	Palma Mallorca	Illes Balears

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitari Son Dureta	Cimera, Fundació d'investigació Sanitària de les Illes Balears

Country where clinical trial is conducted

Spain, 

Outcome

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