NCT03823443

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2021

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

January 29, 2019

Last Update Submit

June 1, 2024

Conditions

Chronic Obstructive Pulmonary DiseaseAcute Exacerbation CopdAlpha-1 Anti-trypsin Deficiency

Keywords

exacerbationcoughsputum

Outcome Measures

Primary Outcomes (1)

  • MMP13 to Alpha-1 antitrypsin ratios

    Serum levels

    1 year

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patient population for this study will have a known diagnosis of COPD, confirmed by pulmonary function testing.

You may qualify if:

  • Diagnosed with COPD (FEV1 \<80% AND FEV1/FVC \< 70%)
  • Ages 35-80yrs

You may not qualify if:

  • History of Asthma
  • Bronchiectasis
  • Carcinoma of the bronchus
  • Recent COPD exacerbation or pulmonary infection (less than 1 month)
  • Other significant respiratory disease
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and nasal swab.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructivealpha 1-Antitrypsin DeficiencyCough

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSubcutaneous EmphysemaEmphysemaRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Monica Goldklang, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine (in Anesthesiology)

Study Record Dates

First Submitted

January 29, 2019

First Posted

January 30, 2019

Study Start

June 7, 2018

Primary Completion

August 22, 2019

Study Completion

January 8, 2021

Last Updated

June 4, 2024

Record last verified: 2024-06

Locations

US(1)