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Identifying Inflammatory Biomarkers of Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00394940
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : December 6, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Chronic Obstructive Pulmonary Disease

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 Design

Study Type : Observational
Actual Enrollment : 2085 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum Inflammatory Biomarkers as Predictors of COPD Morbidity and Mortality
Study Start Date : July 2006
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. COPD development defined as FEV1/FVC < 70% [ Time Frame: up to 50 years ]

Secondary Outcome Measures :
  1. COPD progression defined based on decline of lung function [ Time Frame: up to 50 years ]
  2. Mortality [ Time Frame: up to 50 years ]

Biospecimen Retention:   Samples With DNA
DNA, serum, supernatants

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Sample of the general population that was enrolled in 1972

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394940

United States, Arizona
Arizona Respiratory Center
Tucson, Arizona, United States, 85724-5030
Sponsors and Collaborators
University of Arizona
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Stefano Guerra, MD, PhD Arizona Respiratory Center
More Information

Additional Information:
Responsible Party: Stefano Guerra, Associate Research Professor, University of Arizona
ClinicalTrials.gov Identifier: NCT00394940     History of Changes
Other Study ID Numbers: 1349
R21HL085195-01 ( U.S. NIH Grant/Contract )
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

Keywords provided by Stefano Guerra, University of Arizona:
Chronic Bronchitis

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases