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COPD Exacerbation Blood and Urine Biomarkers Study

COPD Exacerbation Blood and Urine Biomarkers Study

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03823443
Enrollment
7
Registered
2019-01-30
Start date
2018-06-07
Completion date
2021-01-08
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

exacerbation, cough, sputum

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.

Interventions

None listed

Sponsors

Alpha-1 Foundation
CollaboratorOTHER
Columbia University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MMP13 to Alpha-1 antitrypsin ratios1 yearSerum levels

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026