Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05426720

Risk Factors and Biomarkers for Post-tuberculosis Lung Damage

This prospective study aims to determine the incidence of Post-tuberculosis lung damage (PTLD), examine trends in the changes in lung function, and investigate the impact of smoking and other factors on respiratory symptoms, lung function, and chest CT findings, which will aid in the development of prognostic and therapeutic strategies for PTLD.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pulmonary TB Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Behavior Cigarette Smoking Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Smoking Tobacco Smoking Tobacco Use Tuberculosis Tuberculosis, Pulmonary

Age range

25 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

Beijing Geriatric Hospital, Beijing, China

Loading trial locations.

About this study

Introduction: Post-tuberculosis lung damage (PTLD) refers to residual pulmonary impairment following the completion of tuberculosis (TB) treatment, characterized by persistent respiratory symptoms and abnormal pulmonary function. The risk factors and biomarkers for PTLD have been scarcely investigated. Additionally, it remains unclear whether and to what extent cigarette smoking affects PTLD in patients with TB.

Methods and analysis: This prospective observational study will enroll 400 adult male ever-smoker or never-smoker patients aged 25-60 years, with newly confirmed active TB between 2022 and 2024 from the Department of Respiratory and Critical Care Medicine at Peking University Third Hospital and the Tuberculosis Department at Beijing Geriatric Hospital. Baseline data (age, smoking history, and smoking pack-years), clinical symptoms, lung functions, and chest CT (computed tomography) findings will be prospectively collected. Respiratory questionnaires, lung function measurements, and chest CT examinations will be completed during follow-up visits at 6 months after the initiation of TB treatment, immediately at the completion of TB treatment, and at 1 year, 2 years, and 3 years after the completion of TB treatment. Peripheral blood samples will be obtained at baseline to measure inflammatory mediators and cytokines in serum. The collected data will be analyzed to determine the incidence of and factors/biomarkers for PTLD after TB treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male patients aged 25-60 years newly diagnosed with active pulmonary TB.

Exclusion criteria

  • patients with positive sputum smear or TB culture results;
  • human immunodeficiency virus-positive patients;
  • patients infected with multidrug-resistant TB;
  • patients with malignant neoplasms (e.g., lung cancer) or severe cardiovascular and cerebrovascular diseases;
  • non-compliant patients who were unable to complete the lung function tests;
  • patients without lung parenchymal destruction (such as tuberculous pleurisy). -

Treatment and study plan

No intervention

Other

no intervention; This study is a observational study. All patients received routine anti-tuberculosis regimen. Researchers will observe the clinical manifestation, pulmonary function and pulmonary CT manifestation within a few years after the cure of tuberculosis.

Primary outcomes

  1. lung function

    Time frame: half a year, 1 year, 2 year, and 3-year follow-up

    Forced expiratory volume (FEV1, l/min), and forced vital capacity (FVC,l/min) are the important parameters in lung function. FEV1/FVC, diffusing capacity for carbon monoxide (DLCO), and other indicators, will also be observed during follow-up.

Secondary outcomes

  1. Absorption of TB lesions on lung CT scans after TB treatment

    Time frame: half a year, 1 year, 2 year, and 3year follow-up

    Chest CT images will be interpreted by a respiratory physician and a radiologist. Parenchymal and airway lesions detected on CT scans will be recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Sun

CONTACT

Xiaoyan Gai, MD

CONTACT

[email protected]

13522708870

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Beijing Geriatric Hospital

Registry information

Official study title

Risk Factors and Biomarkers for Post-tuberculosis Lung Damage in a Chinese Cohort: Protocol for a Prospective Observational Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Jun 22, 2022
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.