Endothelial Dysfunction in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) (EDAECOPD)

Endothelial Dysfunction and Systemic Inflammation in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease

The purpose of the study is to determine a possible association between the clinical entity of exacerbation, markers of systemic inflammation and endothelial dysfunction in patients with COPD.

Study Overview

• Status: Completed
• Conditions: Endothelial Dysfunction; Chronic Obstructive Pulmonary Disease (COPD); Inflammatory Disease

Detailed Description

Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the lungs; however, there is cumulating data suggesting that the inflammatory reaction associated with COPD is not restricted to the lungs but has systemic effects. Patients with COPD have increased cardiovascular morbidity and mortality. The suspected link between increased cardiovascular mortality and systemic inflammation is endothelial dysfunction, which in turn is caused by impaired activity of NO. Endothelial dysfunction has been demonstrated in patients with COPD. Furthermore there is a close correlation between endothelial dysfunction in coronary and peripheral vessels, which allows assessing flow-mediated dilation (FMD) in the brachial artery via high resolution ultrasound as an early predictor of atherosclerosis. Moreover, systemic inflammatory markers correlate with endothelial dysfunction in patients with stable COPD.

Exacerbations of COPD are episodes of worsening symptoms characterized by increased airway and systemic inflammation. If systemic inflammation is a cause of endothelial dysfunction in COPD, endothelial function would be suspected to be further impaired during exacerbation and recover thereafter. The purpose of this study is to determine a possible association between the clinical entity of exacerbation, markers of systemic inflammation and endothelial dysfunction in patients with COPD.

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • 1.Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD, Otto-Wagner Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD diagnosed according to standard criteria in the state of acute exacerbation

Description

Inclusion Criteria:

• presence of COPD according to standard criteria
• acute exacerbation of COPD according to recommended international criteria
• over 40 years of age
• history of at least 10 py

Exclusion Criteria:

• pneumonia
• history or signs of congestive heart failure,
• acute myocardial infarction
• thoracotomy incl. resection of lungtissue
• interstitial lung disease
• acute or chronic renal failure
• active malignancy
• autoimmune disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Exacerbation; The study sample will consist of patients admitted to the hospital because of an acute exacerbation of COPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change of endothelial dysfunction (impaired vasomotor reactivity due to shaer stress) confirmed by non-invasive measurement of flow mediated dilation (FMD) 6-8 weeks after acute exacerbation of COPD	Baseline, Week 6-8

Secondary Outcome Measures

Outcome Measure	Time Frame
change of systemic inflammation 6-8 weeks after COPD-exacerbation confirmed by inflammatory markers such as interleukin-6 (IL-6), fibrinogen levels, and C-reactive protein (CRP) levels	baseline, week 6-8

Collaborators and Investigators

• Sponsor: LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
• Investigators: Principal Investigator: Georg C Funk, M.D., 1. Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD, Otto-Wagner Hospital, Vienna, Austria

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: October 25, 2011
• First Submitted That Met QC Criteria: October 25, 2011
• First Posted (Estimate): October 26, 2011

Study Record Updates

• Last Update Posted (Estimate): March 12, 2014
• Last Update Submitted That Met QC Criteria: March 10, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: endothelial dysfunction; chronic obstructive pulmonary disease; systemic inflammation; flow mediated dilation; acute exacerbation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: EDAECOPD