- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04966052
COPD Co-infection With Tuberculosis on Th17 Cell Differentiation
July 14, 2021 updated by: Peking University Third Hospital
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Peking University Third Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients seen at Peking University Third Hospital and Beijing Geriatric Hospital Respiratory Department from April 1, 2018 to April 1, 2020
Description
Inclusion Criteria:
- Clinical diagnosis of COPD
- age ≧ 40
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
COPD combined with TB group
COPD combined with pulmonary TB infection
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yongchang Sun, MD, Peking University 3rd Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2018
Primary Completion (Actual)
April 1, 2020
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
July 4, 2021
First Submitted That Met QC Criteria
July 14, 2021
First Posted (Actual)
July 19, 2021
Study Record Updates
Last Update Posted (Actual)
July 19, 2021
Last Update Submitted That Met QC Criteria
July 14, 2021
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Latent Infection
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Infections
- Communicable Diseases
- Tuberculosis
- Latent Tuberculosis
- Coinfection
Other Study ID Numbers
- M2017390
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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