Clinical trial NCT01460082: Endothelial Dysfunction in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Official title: Endothelial Dysfunction and Systemic Inflammation in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Inflammatory Disease
Endothelial Dysfunction
Keywords: chronic obstructive pulmonary disease
acute exacerbation
endothelial dysfunction
flow mediated dilation
systemic inflammation
Lead sponsor: LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
Sponsor class: NETWORK
First posted: 2011-10-26
Enrollment: 29
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD diagnosed according to standard criteria in the state of acute exacerbation

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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Baseline, Week 6-8
Secondary outcomes:
measure: 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
timeFrame: baseline, week 6-8
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: 1.Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD, Otto-Wagner Hospital
Study officials:
affiliation: 1. Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD, Otto-Wagner Hospital, Vienna, Austria
name: Georg C Funk, M.D.
role: PRINCIPAL_INVESTIGATOR
References: