Tuberculosis InfectionNCT04966052
COPD Co-infection With Tuberculosis on Th17 Cell Differentiation
An observational study of Tuberculosis Infection and Chronic Obstructive Pulmonary Disease, run by Peking University Third Hospital at 1 site in China.
Trial summary
This project will observe and follow up the changes of pulmonary function and CT in patients with smoking combined with pulmonary tuberculosis, and measure the ratio of Th1 cells, Th17 cells, macrophages and neutrophils and the secretion of factors such as TNF-α, IFN-γ and IL-17 in pulmonary blood and alveolar lavage… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Tuberculosis Infection, Chronic Obstructive Pulmonary Disease
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 1 Jun 2020
- 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 40 years and older
- All sexes
- Adult, Older adult
Study population: Patients seen at Peking University Third Hospital and Beijing Geriatric Hospital Respiratory Department from April 1, 2018 to April 1, 2020
Who may be able to join
- Clinical diagnosis of COPD
- age ≧ 40
Who cannot join
- Presence of other chronic respiratory diseases other than COPD, such as asthma, bronchiectasis, interstitial lung disease, etc.
- History of chest and lung surgery.
- History of malignancy.
- Autoimmune disease.
- Long-term oral glucocorticoids, immunosuppressants and inhaled glucocorticoids.
- Mental abnormalities, cognitive impairment, inability to cooperate with pulmonary function and other tests.
- Acute stage of infection, such as lung infection, urinary tract infection and gastrointestinal tract infection, etc.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Effect of COPD Co-infection With Tuberculosis on Th17 Cell Differentiation and Its Significance
This project will observe and follow up the changes of pulmonary function and CT in patients with smoking combined with pulmonary tuberculosis, and measure the ratio of Th1 cells, Th17 cells, macrophages and neutrophils and the secretion of factors such as TNF-α, IFN-γ and IL-17 in pulmonary blood and alveolar lavage fluid.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) and tuberculosis are major global health problems, and acquired and acquired immunity play an important role in COPD and tuberculosis, and there is an interaction between COPD and tuberculosis, but the exact mechanism is not clear. Pre-existing TB infection is an independent risk factor for COPD and can aggravate pulmonary function and increase hospitalization and mortality in COPD patients. In COPD patients, Th1 and Th17 cells are involved in the development of COPD and emphysema through activation of macrophages and recruitment of neutrophils, while matrix metalloproteinases (MMPs) of macrophage and neutrophil origin are involved in the formation of tuberculosis cavities, and cytokines such as TNF-α, IFN-γ, IL-17 are involved in the mechanism of their destruction, IL-17 restricts the expression of HIF-1α to inhibit the development of TB granulomas, and CT analysis revealed that combined TB exacerbates emphysema in COPD patients. The above evidence suggests that tuberculosis plays an important role in the formation of emphysema in COPD. In this project, we will observe and follow up the changes of pulmonary function and CT in patients with smoking combined with pulmonary tuberculosis, and examine the ratio of Th1 cells, Th17 cells, macrophages and neutrophils and the secretion of TNF-α, IFN-γ, and IL-17 in pulmonary blood and alveolar lavage fluid.
- Being tested
- No intervention
- Medical subject headings
- Latent Tuberculosis, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| COPD combined with TB group | COPD combined with pulmonary TB infection Receives: Other: No intervention | |
| COPD non-TB control group | COPD combined without pulmonary TB infection | |
| TB non-COPD control group | pulmonary TB infection without COPD | |
| Non-smoking non-TB control group | Non-smoking without pulmonary TB infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentiation of Th17 cells
Distribution of T cell subtypes, including CD4+, CD8+ T cells and Th17 cells, in blood specimens and alveolar lavage fluid by flow cytometry
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Apr 2018
- Primary completion1 Apr 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis InfectionStudies of the same condition, open and under way.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Geriatric Hospital
- Responsible party
- Sponsor
- Investigators
- Yongchang Sun, MD, Principal investigator, Peking University 3rd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966052
- Sponsor's protocol ID
- M2017390
- Status last verified
- Jul 2020
- First submitted
- 4 Jul 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gai X, Cao W, Rao Y, Zeng L, Xu W, Wu H, Li G, Sun Y. Risk factors and biomarkers for post-tuberculosis lung damage in a Chinese cohort of male smokers and non-smokers: protocol for a prospective observational study. BMJ Open. 2023 Oct 9;13(10):e065990. doi: 10.1136/bmjopen-2022-065990.
PubMed 37813532
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of COPD Co-infection With Tuberculosis on Th17 Cell Differentiation and Its Significance
- ClinicalTrials.gov ID
- NCT04966052
- Acronym / sponsor ID
- M2017390
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Geriatric Hospital
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 19 Jul 2021 (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 project will observe and follow up the changes of pulmonary function and CT in patients with smoking combined with pulmonary tuberculosis, and measure the ratio of Th1 cells, Th17 cells, macrophages and neutrophils and the secretion of factors such as TNF-α, IFN-γ and IL-17 in pulmonary blood and alveolar lavage fluid.
Detailed description
Chronic obstructive pulmonary disease (COPD) and tuberculosis are major global health problems, and acquired and acquired immunity play an important role in COPD and tuberculosis, and there is an interaction between COPD and tuberculosis, but the exact mechanism is not clear. Pre-existing TB infection is an independent risk factor for COPD and can aggravate pulmonary function and increase hospitalization and mortality in COPD patients. In COPD patients, Th1 and Th17 cells are involved in the development of COPD and emphysema through activation of macrophages and recruitment of neutrophils, while matrix metalloproteinases (MMPs) of macrophage and neutrophil origin are involved in the formation of tuberculosis cavities, and cytokines such as TNF-α, IFN-γ, IL-17 are involved in the mechanism of their destruction, IL-17 restricts the expression of HIF-1α to inhibit the development of TB granulomas, and CT analysis revealed that combined TB exacerbates emphysema in COPD patients. The above evidence suggests that tuberculosis plays an important role in the formation of emphysema in COPD. In this project, we will observe and follow up the changes of pulmonary function and CT in patients with smoking combined with pulmonary tuberculosis, and examine the ratio of Th1 cells, Th17 cells, macrophages and neutrophils and the secretion of TNF-α, IFN-γ, and IL-17 in pulmonary blood and alveolar lavage fluid.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COPD combined with TB group | – | Other: No interventionCOPD combined with pulmonary TB infection |
| COPD non-TB control group | – | –COPD combined without pulmonary TB infection |
| TB non-COPD control group | – | –pulmonary TB infection without COPD |
| Non-smoking non-TB control group | – | –Non-smoking without pulmonary TB infection |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients seen at Peking University Third Hospital and Beijing Geriatric Hospital Respiratory Department from April 1, 2018 to April 1, 2020
Key inclusion criteria (2 listed)
- Clinical diagnosis of COPD
- age ≧ 40
Key exclusion criteria (7 listed)
- Presence of other chronic respiratory diseases other than COPD, such as asthma, bronchiectasis, interstitial lung disease, etc.
- History of chest and lung surgery.
- History of malignancy.
- Autoimmune disease.
- Long-term oral glucocorticoids, immunosuppressants and inhaled glucocorticoids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | COPD combined with TB group |
Primary outcome
Differentiation of Th17 cells
Time frame: Day 1
Distribution of T cell subtypes, including CD4+, CD8+ T cells and Th17 cells, in blood specimens and alveolar lavage fluid by flow cytometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Derived from this study: PubMed 37813532Gai X, Cao W, Rao Y, Zeng L, Xu W, Wu H, Li G, Sun Y. Risk factors and biomarkers for post-tuberculosis lung damage in a Chinese cohort of male smokers and non-smokers: protocol for a prospective observational study. BMJ Open. 2023 Oct 9;13(10):e065990. doi: 10.1136/bmjopen-2022-065990.
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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.
Yongchang Sun, MD principal investigator
Peking University 3rd Hospital
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 Tuberculosis Infection and Chronic Obstructive Pulmonary Disease, run by Peking University Third Hospital at 1 site in China.
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 7 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: finished, as of the sponsor's last update on 19 Jul 2021. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differentiation of Th17 cells (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04966052, which also lists 1 linked publication.
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 19 Jul 2021.