Clinical trial NCT00394940: Identifying Inflammatory Biomarkers of Chronic Obstructive Pulmonary Disease
Official title: Serum Inflammatory Biomarkers as Predictors of COPD Morbidity and Mortality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Emphysema
Chronic Bronchitis
Inflammation
CD14
TLR4
Proteomics
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2006-11-02
Enrollment: 2085
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sample of the general population that was enrolled in 1972

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: COPD development defined as FEV1/FVC < 70%
timeFrame: up to 50 years
Secondary outcomes:
measure: COPD progression defined based on decline of lung function
timeFrame: up to 50 years
measure: Mortality
timeFrame: up to 50 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Respiratory Center
state: Arizona
Study officials:
affiliation: Arizona Respiratory Center
name: Stefano Guerra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: