Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01460082
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):
Matthias Urban, LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
Chronic Obstructive Pulmonary Disease (COPD) Inflammatory Disease Endothelial Dysfunction

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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
Serum, Plasma

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Study Population
Patients with COPD diagnosed according to standard criteria in the state of acute exacerbation
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
Austria
1.Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD, Otto-Wagner Hospital
Vienna, Austria, 1140
Sponsors and Collaborators
LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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
Keywords provided by Matthias Urban, LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology:
chronic obstructive pulmonary disease
acute exacerbation
endothelial dysfunction
flow mediated dilation
systemic inflammation
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases