Chronic Obstructive Pulmonary DiseaseNCT03823443
COPD Exacerbation Blood and Urine Biomarkers Study
An observational study of Chronic Obstructive Pulmonary Disease and Acute Exacerbation Copd, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Acute Exacerbation Copd, Alpha-1 Anti-trypsin Deficiency
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2018to 8 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient population for this study will have a known diagnosis of COPD, confirmed by pulmonary function testing.
Who may be able to join
- Diagnosed with COPD (FEV1 <80% AND FEV1/FVC < 70%)
- Ages 35-80yrs
Who cannot join
- History of Asthma
- Bronchiectasis
- Carcinoma of the bronchus
- Recent COPD exacerbation or pulmonary infection (less than 1 month)
- Other significant respiratory disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease, Acute Exacerbation Copd, Alpha-1 Anti-trypsin Deficiency
- Keywords
- exacerbation, cough, sputum
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, alpha 1-Antitrypsin Deficiency, Cough
What is being measured
The primary outcome is the main question the study is designed to answer.
MMP13 to Alpha-1 antitrypsin ratios
Serum levels
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start7 Jun 2018
- Primary completion22 Aug 2019
- Study completion8 Jan 2021
Why it stopped: Difficulty enrolling
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Alpha-1 Foundation
- Responsible party
- Principal investigator, Monica Goldklang, Columbia University
- Investigators
- Monica Goldklang, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823443
- Sponsor's protocol ID
- AAAR3691
- Status last verified
- Jun 2024
- First submitted
- 29 Jan 2019
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPD Exacerbation Blood and Urine Biomarkers Study
- ClinicalTrials.gov ID
- NCT03823443
- Acronym / sponsor ID
- AAAR3691
- Conditions
- Chronic Obstructive Pulmonary Disease, Acute Exacerbation Copd, Alpha-1 Anti-trypsin Deficiency
- Keywords
- exacerbation, cough, sputum
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Alpha-1 Foundation
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population for this study will have a known diagnosis of COPD, confirmed by pulmonary function testing.
Key inclusion criteria (2 listed)
- Diagnosed with COPD (FEV1 <80% AND FEV1/FVC < 70%)
- Ages 35-80yrs
Key exclusion criteria (6 listed)
- History of Asthma
- Bronchiectasis
- Carcinoma of the bronchus
- Recent COPD exacerbation or pulmonary infection (less than 1 month)
- Other significant respiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MMP13 to Alpha-1 antitrypsin ratios
Time frame: 1 year
Serum levels
Results and safety
The study was stopped early (reason given: Difficulty enrolling). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Goldklang, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Acute Exacerbation Copd, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty enrolling). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMP13 to Alpha-1 antitrypsin ratios (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.