COPD Exacerbation Blood and Urine Biomarkers Study

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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