Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Sponsor University of Arizona
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date July 2006
End date January 2022
Trial size 1200 participants
Trial identifier NCT00394940, 1349, R21HL085195-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
COPD development defined as FEV1/FVC < 70%
time frame: up to 50 years

Secondary Outcomes

Measure
COPD progression defined based on decline of lung function
time frame: up to 50 years
Mortality
time frame: up to 50 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Enrolled in the Tucson Epidemiological Study of Airway Obstructive Disease (TESAOD)

Additional Information

Official title Serum Inflammatory Biomarkers as Predictors of COPD Morbidity and Mortality
Principal investigator Stefano Guerra, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Arizona.