Brief Title
COPD Exacerbation Blood and Urine Biomarkers Study
Official Title
COPD Exacerbation Blood and Urine Biomarkers Study
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.
Study Type
Observational
Primary Outcome
MMP13 to Alpha-1 antitrypsin ratios
Condition
Chronic Obstructive Pulmonary Disease
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
60
Start Date
June 7, 2018
Completion Date
August 30, 2021
Primary Completion Date
August 30, 2021
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
Gender
All
Ages
35 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Monica Goldklang, MD, 212-305-3745, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03823443
Organization ID
AAAR3691
Responsible Party
Principal Investigator
Study Sponsor
Columbia University
Collaborators
Alpha-1 Foundation
Study Sponsor
Monica Goldklang, MD, Principal Investigator, Columbia University
Verification Date
May 2020