Investigating lung damage after tuberculosis treatment

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

This study is trying to see how many people have lung damage after finishing tuberculosis treatment and how smoking and other factors affect their breathing and lung health.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 25 Years to 60 Years
• Sex: Male
• Sponsor: Peking University Third Hospital (Academic / other)
• Locations: 2 sites (Beijing and 1 other locations)
• Trial ID: NCT05426720 on ClinicalTrials.gov

What this trial studies

This prospective observational study aims to assess the incidence of post-tuberculosis lung damage (PTLD) and explore the influence of smoking and other factors on lung function and respiratory symptoms in patients who have completed tuberculosis treatment. It will enroll 400 adult male patients aged 25-60 years with newly confirmed active pulmonary TB, collecting baseline data and conducting follow-up assessments over three years. The study will analyze clinical symptoms, lung function, chest CT findings, and inflammatory biomarkers to develop prognostic and therapeutic strategies for PTLD.

Who should consider this trial

Good fit: Ideal candidates are male patients aged 25-60 years who have newly diagnosed active pulmonary tuberculosis.

Not a fit: Patients with multidrug-resistant TB, HIV-positive status, or significant comorbidities such as lung cancer or severe cardiovascular diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and treatment strategies for patients suffering from post-tuberculosis lung damage.

How similar studies have performed: While the investigation of post-tuberculosis lung damage is relatively novel, similar studies have shown that understanding risk factors can lead to better patient outcomes.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Where this trial is running

Beijing and 1 other locations

• Peking University Third Hospital — Beijing, China (Recruiting)
• Beijing Geriatric Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Xiaoyan Gai, MD

Conditions Pulmonary TB; post-tuberculosis lung damage; cigarette smoking