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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04966052
Other study ID # M2017390
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date June 1, 2020

Study information

Verified date July 2020
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 fluid.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 1, 2020
Est. primary completion date April 1, 2020
Accepts healthy volunteers
Gender All
Age group 40 Years and older
Eligibility 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 Design


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Peking University Third Hospital Beijing Geriatric Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 1
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