Identifying Inflammatory Biomarkers of Chronic Obstructive Pulmonary Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Stefano Guerra, University of Arizona
ClinicalTrials.gov Identifier:
NCT00394940
First received: October 31, 2006
Last updated: June 2, 2016
Last verified: June 2016
  Purpose
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
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum Inflammatory Biomarkers as Predictors of COPD Morbidity and Mortality

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • COPD development defined as FEV1/FVC < 70% [ Time Frame: up to 50 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • COPD progression defined based on decline of lung function [ Time Frame: up to 50 years ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: up to 50 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
DNA, serum, supernatants

Estimated Enrollment: 1200
Study Start Date: July 2006
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)
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

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

Inclusion Criteria:

  • Enrolled in the Tucson Epidemiological Study of Airway Obstructive Disease (TESAOD)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394940

Locations
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)
Investigators
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 
Study First Received: October 31, 2006
Last Updated: June 2, 2016
Health Authority: United States: Federal Government

Keywords provided by University of Arizona:
COPD
Emphysema
Chronic Bronchitis
Inflammation
CD14
TLR4
Proteomics

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

ClinicalTrials.gov processed this record on July 27, 2016