Chronic Obstructive Pulmonary DiseaseNCT06101459
A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients
An observational study of Chronic Obstructive Pulmonary Disease, run by Asan Medical Center.
Trial summary
The goal of this observational registry study is to compare characteristics of gut and sputum microbiome and metabolome among COPD patients with significant smoking history, COPD patients without significant smoking history and healthy smoker. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 31 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 1. COPD patients with significant smoking history * FEV1/FVC <0.7 in spirometry * Smoking history at least 30 pack-year 2. COPD patients without significant smoking history * FEV1/FVC <0.7 in spirometry * No smoking history or smoking history at less than 0.5 pack-year 3. Healthy smoker * FEV1/FVC ≥0.7 in spirometry * Smoking history at least 30 pack-year
Who may be able to join
- COPD Patients, defined by FEV1/FVC <0.7, who
- agree with informed consent
- have no history of acute exacerbation within 3 months
- Healthy smoker without airflow limitation, defined by FEV1/FVC ≥0.7, who
- have smoking history with at least 30 pack-year
- agree with informed consent
- do not use medication for chronic respiratory disease
Who cannot join
- Withdrawal of informed consent
- History of acute exacerbation or antibiotics use within 3 months
- Difficulty to collect adequate stool, sputum and blood samples
About this study
The goal of this observational registry study is to compare characteristics of gut and sputum microbiome and metabolome among COPD patients with significant smoking history, COPD patients without significant smoking history and healthy smoker. Additionally, the investigators investigate the difference of blood metabolites and peripheral blood mononuclear cells level among groups.
The main questions it aims to answer are:
- Are there significant difference in fecal or sputum microbiome and metabolome between COPD patients and healthy smoker?
- Are there any distinct characteristics in microbiome and metabolome in COPD with COPD patients with significant smoking history, COPD patients without significant smoking history compared with healthy smoker?
- Are there any difference in blood metabolites and peripheral blood mononuclear cells levels among patients with significant smoking history, COPD patients without significant smoking history and healthy smoker
- Might distinct characteristics of microbiome and metabolites in COPD patients be related to worse clinical outcomes in COPD patients?
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Microbiome, Metabolome, Smoking history
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD patient with significant smoking history | Patients with following conditions 1. smoking history more than 30 pack*year 2. FEV1/FVC ratio <0.7 3. No acute exacerbation history within 3 months | |
| COPD patient without significant smoking history | Patients with following conditions 1. smoking history less than 0.5 pack*year 2. FEV1/FVC ratio <0.7 3. No acute exacerbation history within 3 months | |
| Healthy smoker | Patients with following conditions 1. smoking history more than 30 pack*year 2. FEV1/FVC ratio ≥0.7 3. No current use of medication for any chronic respiratory disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shannon diversity index
the investigators will compare alpha diversity and community similarity among groups by using the Shannon diversity index.
Measured: At enrollment
Simpson index
the investigators will compare alpha diversity and community similarity among groups by using the Simpson index.
Measured: At enrollment
Principal component analysis
the investigators will compare beta diversity and community similarity among groups by using the principal component analysis.
Measured: At enrollment
Microbiome composition by metagenomic analysis
The composition of microbiome will be presented as bar graph.
Measured: At enrollment
Peripheral blood mononuclear cells level
the investigators will compare the Peripheral blood mononuclear cells level among groups
Measured: At enrollment
Acetic acid level
the investigators will compare the acetic acid level among groups
Measured: At enrollment
Propionic acid level
the investigators will compare the Propionic acid level among groups
Measured: At enrollment
Isobutyric acid level
the investigators will compare the Isobutyric acid level among groups
Measured: At enrollment
Butyric acid level
the investigators will compare the butyric acid level among groups
Measured: At enrollment
Isovaleric acid level
the investigators will compare the Isovaleric acid level among groups
Measured: At enrollment
Valeric acid level
the investigators will compare the valeric acid level among groups
Measured: At enrollment
dimethylglycine level
the investigators will compare the dimethylglycine level among groups
Measured: At enrollment
secondary bile acid level
the investigators will compare the secondary bile acid level among groups
Measured: At enrollment
Secondary outcomes (4)
Difference of microbiome according to Exacerbation
the investigators will investigate the baseline difference of microbiome between COPD patients with moderate to severe exacerbation and COPD patients without moderate to severe exacerbation
Measured: within 1 year after enrollment
Difference of metabolome according to Exacerbation
the investigators will investigate the baseline difference of metabolome between COPD patients with moderate to severe exacerbation and COPD patients without moderate to severe exacerbation
Measured: within 1 year after enrollment
Difference of microbiome according to death
the investigators will investigate the baseline difference of microbiome between COPD patients with death and COPD patients without death
Measured: within 1 year after enrollment
Difference of metabolome according to death
the investigators will investigate the baseline difference of metabolome between COPD patients with death and COPD patients without death
Measured: within 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
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 Asan Medical CenterThe 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
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University College of Medicine, HEM Pharma Inc.
- Responsible party
- Principal investigator, Sei Won Lee, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101459
- Sponsor's protocol ID
- 2023-1049
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients
- ClinicalTrials.gov ID
- NCT06101459
- Acronym / sponsor ID
- 2023-1049
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Microbiome, Metabolome, Smoking history
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Seoul National University College of Medicine, HEM Pharma Inc.
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Oct 2023 (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.
The goal of this observational registry study is to compare characteristics of gut and sputum microbiome and metabolome among COPD patients with significant smoking history, COPD patients without significant smoking history and healthy smoker. Additionally, the investigators investigate the difference of blood metabolites and peripheral blood mononuclear cells level among groups.
The main questions it aims to answer are:
- Are there significant difference in fecal or sputum microbiome and metabolome between COPD patients and healthy smoker?
- Are there any distinct characteristics in microbiome and metabolome in COPD with COPD patients with significant smoking history, COPD patients without significant smoking history compared with healthy smoker?
- Are there any difference in blood metabolites and peripheral blood mononuclear cells levels among patients with significant smoking history, COPD patients without significant smoking history and healthy smoker
- Might distinct characteristics of microbiome and metabolites in COPD patients be related to worse clinical outcomes in COPD patients?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD patient with significant smoking history | – | –Patients with following conditions 1. smoking history more than 30 pack*year 2. FEV1/FVC ratio <0.7 3. No acute exacerbation history within 3 months |
| COPD patient without significant smoking history | – | –Patients with following conditions 1. smoking history less than 0.5 pack*year 2. FEV1/FVC ratio <0.7 3. No acute exacerbation history within 3 months |
| Healthy smoker | – | –Patients with following conditions 1. smoking history more than 30 pack*year 2. FEV1/FVC ratio ≥0.7 3. No current use of medication for any chronic respiratory disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. COPD patients with significant smoking history * FEV1/FVC <0.7 in spirometry * Smoking history at least 30 pack-year 2. COPD patients without significant smoking history * FEV1/FVC <0.7 in spirometry * No smoking history or smoking history at less than 0.5 pack-year 3. Healthy smoker * FEV1/FVC ≥0.7 in spirometry * Smoking history at least 30 pack-year
Key inclusion criteria (7 listed)
- COPD Patients, defined by FEV1/FVC <0.7, who
- Healthy smoker without airflow limitation, defined by FEV1/FVC ≥0.7, who
Key exclusion criteria (3 listed)
- Withdrawal of informed consent
- History of acute exacerbation or antibiotics use within 3 months
- Difficulty to collect adequate stool, sputum and blood samples
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
Shannon diversity index
Time frame: At enrollment
the investigators will compare alpha diversity and community similarity among groups by using the Shannon diversity index.
Simpson index
Time frame: At enrollment
the investigators will compare alpha diversity and community similarity among groups by using the Simpson index.
Principal component analysis
Time frame: At enrollment
the investigators will compare beta diversity and community similarity among groups by using the principal component analysis.
Microbiome composition by metagenomic analysis
Time frame: At enrollment
The composition of microbiome will be presented as bar graph.
Peripheral blood mononuclear cells level
Time frame: At enrollment
the investigators will compare the Peripheral blood mononuclear cells level among groups
Acetic acid level
Time frame: At enrollment
the investigators will compare the acetic acid level among groups
Propionic acid level
Time frame: At enrollment
the investigators will compare the Propionic acid level among groups
Isobutyric acid level
Time frame: At enrollment
the investigators will compare the Isobutyric acid level among groups
Butyric acid level
Time frame: At enrollment
the investigators will compare the butyric acid level among groups
Isovaleric acid level
Time frame: At enrollment
the investigators will compare the Isovaleric acid level among groups
Valeric acid level
Time frame: At enrollment
the investigators will compare the valeric acid level among groups
dimethylglycine level
Time frame: At enrollment
the investigators will compare the dimethylglycine level among groups
secondary bile acid level
Time frame: At enrollment
the investigators will compare the secondary bile acid level among groups
4 secondary outcomes
Difference of microbiome according to Exacerbation
Time frame: within 1 year after enrollment
Difference of metabolome according to Exacerbation
Time frame: within 1 year after enrollment
Difference of microbiome according to death
Time frame: within 1 year after enrollment
Difference of metabolome according to death
Time frame: within 1 year after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Asan Medical Center.
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 7 inclusion and 3 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: opening soon, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Shannon diversity index (time frame: At enrollment). The study lists 13 primary outcomes in all. 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 26 Oct 2023.