COPD Exacerbation Blood and Urine Biomarkers Study

NCT ID: NCT03823443

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-07
• Study Completion Date: 2021-01-08

Brief Summary

This will be a prospective study examining serum levels of MMP-13 and alpha-1 antitrypsin as well as other biomarkers as well as urine biomarkers of smoking status and collagen degradation in the COPD patient population. Serum and urine biomarkers at baseline and after COPD exacerbations will be assessed against change in lung function as measured by pulmonary function testing.

Detailed Description

Chronic obstructive pulmonary disease (COPD), a term describing emphysema and chronic bronchitis, is the third leading cause of death in the United States, with approximately 24 million US adults estimated to have the disease and over 130,000 US adults dying each year due to COPD. Acute exacerbations of chronic obstructive pulmonary disease (AECOPD), primarily the result of viral respiratory infections, result in accelerated decline in lung function and increased mortality. Recent work in our laboratory demonstrates that matrix metalloproteinase-13 (MMP-13), which has both collagenolytic and elastolytic activity, is increased in the bronchoalveolar lavage fluid of patients with COPD. It is well accepted that viral infections have significant consequences in smokers, particularly in patients with AATD related COPD.

COPD exacerbations clinically manifest with increased dyspnea, cough and sputum production, and from a societal cost standpoint are associated with significant increases in health care utilization. Recent data suggest that viral infections such as RSV increase MMP-13 secretion and expression within lung tissues. Therefore, the studies presented here seek to understand the effect of MMP-13 on COPD progression and the effect of disease exacerbations on MMP-13 and alpha-1 antitrypsin serum levels and later lung function decline. The investigators hypothesize that patients with COPD, in particular patients who fall into the "frequent exacerbator" phenotype (two or more exacerbations within the last year), will have increased levels of MMP-13 as compared to the general non-COPD patient population and that in the setting of a COPD exacerbation, levels will be increased. The investigators will assess how exacerbation MMP-13 levels predict later lung function decline.

Conditions

Chronic Obstructive Pulmonary Disease; Acute Exacerbation Copd; Alpha-1 Anti-trypsin Deficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Diagnosed with COPD (FEV1 <80% AND FEV1/FVC < 70%)
• Ages 35-80yrs

Exclusion Criteria

• History of Asthma
• Bronchiectasis
• Carcinoma of the bronchus
• Recent COPD exacerbation or pulmonary infection (less than 1 month)
• Other significant respiratory disease
• Pregnancy

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alpha-1 Foundation

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Monica Goldklang

Assistant Professor of Medicine (in Anesthesiology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monica Goldklang, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAR3691

Identifier Type: -

Identifier Source: org_study_id