NCT04966052

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

July 4, 2021

Last Update Submit

July 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

COPD combined with TB group

COPD combined with pulmonary TB infection

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

Interventions

No intervention

COPD combined with TB group

Eligibility Criteria

Age40 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Clinical diagnosis of COPD
  • age ≧ 40

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

The distribution of T-cell subtypes, including CD4+ and CD8+ T cells and Th17 cells, in blood specimens and alveolar lavage fluid was detected by flow cytometry.

MeSH Terms

Conditions

Latent TuberculosisPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent InfectionLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yongchang Sun, MD

    Peking University 3rd Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2021

First Posted

July 19, 2021

Study Start

April 1, 2018

Primary Completion

April 1, 2020

Study Completion

June 1, 2020

Last Updated

July 19, 2021

Record last verified: 2020-07

Locations