Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831220
• Other study ID #: PI04/1946
• Status: Completed
• Phase: N/A
• First received: January 27, 2009
• Last updated: January 27, 2009
• Start date: March 2005
• Est. completion date: October 2007

Study information

• Verified date: January 2009
• Source: Hospital Universitari Son Dureta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Objective: To investigate the potential role of endothelial dysfunction as a pathogenic mechanism of cardiovascular events in COPD. Hypothesis: endothelial function is abnormal in patients with COPD, particularly during exacerbations of the disease. Design: prospective and controlled study performed in an university hospital. Population: we compare 4 groups of subjects, 44 patients with stable COPD, 35 patients with acute exacerbation of COPD, 10 smokers or former smokers with normal lung function and 10 never smokers matched by physical activity and BMI. Study variables: a) clinical variables: clinical information, physical examination, pulmonary function tests, ECG and sputum culture; b) Biological variables: number of Circulating Endothelial Progenitor Cells, vascular growth factors (vascular endothelial growht factor and erythropoietin), systemic inflammation (C-reactive protein, white blood cells), peripheral venous blood test (including hemogram, biochemical analysis with glycemia, cholesterol, LDLcol, HDLcol); and c) systemic vascular reactivity assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Patients with moderate to very severe COPD admitted in the hospital because of an exacerbation, and,

• Patients with moderate to very severe COPD in stable condition.

Exclusion Criteria:

• Patients with an exacerbation of COPD who needed invasive or non invasive mechanical ventilation

• Patients with other chronic inflammatory diseases.

• Patients with other acute or active chronic systemic disease such as heart failure, renal insufficiency, etc.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Spain	Hospital Universitari Son Dureta	Palma Mallorca	Illes Balears

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Son Dureta	Fondo de Investigacion Sanitaria

Country where clinical trial is conducted

Spain,