Endothelial Dysfunction in Acute Exacerbations of Chronic... | NCT01460082

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

NCT01460082

Sponsor

LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology

Status

Completed

Last Update Posted

Mar 12, 2014Estimated

Enrollment

29Actual

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease (COPD)
Inflammatory Disease
Endothelial Dysfunction

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Oct 25, 2011

First Submission Date that Met QC Criteria

Oct 25, 2011

First Posted Date

Oct 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2014

Last Update Posted Date

Mar 12, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthias Urban, M.D., Study coordinator, LudwLudwig Boltzmann Institute for COPD and Respiratory EpidemiologyPrincipal Investigator

Lead Sponsor

LudwLudwig Boltzmann Institute for COPD and Respiratory EpidemiologyNETWORK

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exacerbation		The study sample will consist of patients admitted to the hospital because of an acute exacerbation of COPD

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georg C Funk, M.D.	1. Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD, Otto-Wagner Hospital, Vienna, Austria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
1.Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD, Otto-Wagner Hospital		Vienna	State of Vienna	1140	Austria

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

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Browse Branches

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