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Completed

NCT Number: NCT00394940

Identifying Inflammatory Biomarkers of Chronic Obstructive Pulmonary Disease

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Disease Disease Attributes Emphysema Infections Inflammation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Arizona Respiratory Center

Tucson, Arizona, 85724-5030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. COPD development defined as FEV1/FVC < 70%

    Time frame: up to 50 years

Secondary outcomes

  1. COPD progression defined based on decline of lung function

    Time frame: up to 50 years

  2. Mortality

    Time frame: up to 50 years

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Serum Inflammatory Biomarkers as Predictors of COPD Morbidity and Mortality

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Nov 2, 2006
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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