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Clinical Trials/NCT00394940
NCT00394940
Completed
Not Applicable

Serum Inflammatory Biomarkers as Predictors of COPD Morbidity and Mortality

University of Arizona1 site in 1 country2,085 target enrollmentJuly 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
University of Arizona
Enrollment
2085
Locations
1
Primary Endpoint
COPD development defined as FEV1/FVC < 70%
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a condition that is characterized by airway obstruction due to inflammation. Levels of inflammatory proteins may be linked to when and to what extent COPD develops. This study will use data collected during the Tucson Epidemiological Study of Airway Obstructive Disease (TESAOD) and its 33-year follow-up to determine the relationship between inflammatory protein expression and COPD.

Detailed Description

COPD is a term that encompasses both chronic bronchitis and emphysema, two diseases that are characterized by airway obstruction that interferes with normal breathing. Airway inflammation can stem from exposure to harmful fumes in the air, chronic bacterial infections in the airways, and a genetic predisposition to an inflammatory response to these agents. In people with COPD, the airway inflammation may extend beyond the lungs and contribute to systemic symptoms and, ultimately, to an increased mortality risk. Markers of systemic inflammation have been identified, but the relationship between these markers and when and to what extent COPD develops has not been determined. This study will use data collected during the TESAOD and its 33-year follow-up to determine the relationship between COPD and the expression of various inflammatory proteins, including pro-inflammatory cytokines (e.g., IL-6, IL-8, TNF-alpha) and acute phase proteins (e.g., C-reactive protein, soluble CD14). This study will not recruit any new participants. Detailed respiratory phenotypic information and serum samples that were collected during the TESAOD study will be evaluated in conjunction with newly generated biomarker and protein information. No new phenotypic data or biological specimens will be collected in this study.

Registry
clinicaltrials.gov
Start Date
July 2006
End Date
January 2013
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stefano Guerra

Associate Research Professor

University of Arizona

Eligibility Criteria

Inclusion Criteria

  • Enrolled in the Tucson Epidemiological Study of Airway Obstructive Disease (TESAOD)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

COPD development defined as FEV1/FVC < 70%

Time Frame: up to 50 years

Secondary Outcomes

  • COPD progression defined based on decline of lung function(up to 50 years)
  • Mortality(up to 50 years)

Study Sites (1)

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