Endothelial Dysfunction in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) (EDAECOPD)
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ClinicalTrials.gov Identifier: NCT01460082 |
Recruitment Status :
Completed
First Posted : October 26, 2011
Last Update Posted : March 12, 2014
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Condition or disease |
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Chronic Obstructive Pulmonary Disease (COPD) Inflammatory Disease Endothelial Dysfunction |
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 |
Actual Enrollment : | 29 participants |
Observational Model: | Case-Only |
Time Perspective: | Cross-Sectional |
Official Title: | Endothelial Dysfunction and Systemic Inflammation in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease |
Study Start Date : | August 2008 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |

Group/Cohort |
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Exacerbation
The study sample will consist of patients admitted to the hospital because of an acute exacerbation of COPD
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- 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 [ Time Frame: Baseline, Week 6-8 ]
- 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 [ Time Frame: baseline, week 6-8 ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460082
Austria | |
1.Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD, Otto-Wagner Hospital | |
Vienna, Austria, 1140 |
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 |
Responsible Party: | Matthias Urban, M.D., Study coordinator, LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology |
ClinicalTrials.gov Identifier: | NCT01460082 |
Other Study ID Numbers: |
EDAECOPD |
First Posted: | October 26, 2011 Key Record Dates |
Last Update Posted: | March 12, 2014 |
Last Verified: | March 2014 |
chronic obstructive pulmonary disease acute exacerbation endothelial dysfunction flow mediated dilation systemic inflammation |
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |