- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00394940
Identifying Inflammatory Biomarkers of Chronic Obstructive Pulmonary Disease
Serum Inflammatory Biomarkers as Predictors of COPD Morbidity and Mortality
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724-5030
- Arizona Respiratory Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Enrolled in the Tucson Epidemiological Study of Airway Obstructive Disease (TESAOD)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
COPD development defined as FEV1/FVC < 70%
Time Frame: up to 50 years
|
up to 50 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
COPD progression defined based on decline of lung function
Time Frame: up to 50 years
|
up to 50 years
|
|
Mortality
Time Frame: up to 50 years
|
up to 50 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stefano Guerra, MD, PhD, Arizona Respiratory Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1349
- R21HL085195-01 (U.S. NIH Grant/Contract)
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