Risk Factors and Biomarkers for Post-tuberculosis Lung Damage

ConditionPulmonary TB

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexMale

Age25-60

SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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;

Trial population

This prospective observational study will enroll male patients who were newly diagnosed with active TB from the Department of Respiratory and Critical Care Medicine at Peking University Third Hospital and the Tuberculosis Department at Beijing Geriatric Hospital between January 2022 and December 2024.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

no intervention
Other intervention
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.

Treatment groups

400 Participants

are divided into 1 treatment group

Group A: patients with pulmonary tuberculosis1 intervention

Trial outcomes

Primary outcomes

lung function

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.

Time frame

half a year, 1 year, 2 year, and 3-year follow-up

Secondary outcomes

Absorption of TB lesions on lung CT scans after TB treatment

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

Time frame

half a year, 1 year, 2 year, and 3year follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Third Hospital

Lead sponsor

Beijing Geriatric Hospital

Collaborator

Source ClinicalTrials.gov

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