Clinical trial NCT03823443: COPD Exacerbation Blood and Urine Biomarkers Study
Official title: COPD Exacerbation Blood and Urine Biomarkers Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Obstructive Pulmonary Disease
Acute Exacerbation Copd
Alpha-1 Anti-trypsin Deficiency
Keywords: exacerbation
cough
sputum
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Alpha-1 Foundation
First posted: 2019-01-30
Enrollment: 7
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient population for this study will have a known diagnosis of COPD, confirmed by pulmonary function testing.

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.

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

Primary outcomes:
measure: MMP13 to Alpha-1 antitrypsin ratios
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Monica Goldklang, MD
role: PRINCIPAL_INVESTIGATOR
References: