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COPD Exacerbation Blood and Urine Biomarkers Study

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ClinicalTrials.gov Identifier: NCT03823443
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
Alpha-1 Foundation
Information provided by (Responsible Party):
Monica Goldklang, Columbia University

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.

Condition or disease
Chronic Obstructive Pulmonary Disease Acute Exacerbation Copd Alpha-1 Anti-trypsin Deficiency

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
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COPD Exacerbation Blood and Urine Biomarkers Study
Actual Study Start Date : June 7, 2018
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021





Primary Outcome Measures :
  1. MMP13 to Alpha-1 antitrypsin ratios [ Time Frame: 1 year ]
    Serum levels


Biospecimen Retention:   Samples With DNA
Blood, urine and nasal swab.


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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patient population for this study will have a known diagnosis of COPD, confirmed by pulmonary function testing.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823443


Contacts
Contact: Monica Goldklang, MD 212-305-3745 mpg2124@cumc.columbia.edu
Contact: Laura Fonseca 212-305-3745 lf2560@cumc.columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Monica Goldklang, MD    212-305-3745    mpg2124@cumc.columbia.edu   
Contact: Laura Fonseca    212-305-3745    lf2560@cumc.columbia.edu   
Principal Investigator: Monica Goldklang, MD         
Sponsors and Collaborators
Columbia University
Alpha-1 Foundation
Investigators
Principal Investigator: Monica Goldklang, MD Columbia University

Responsible Party: Monica Goldklang, Assistant Professor of Medicine (in Anesthesiology), Columbia University
ClinicalTrials.gov Identifier: NCT03823443     History of Changes
Other Study ID Numbers: AAAR3691
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Monica Goldklang, Columbia University:
exacerbation
cough
sputum

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Alpha 1-Antitrypsin Deficiency
Respiratory Tract Diseases
Liver Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Emphysema
Pathologic Processes