Study of N-acetylcysteine NAC with Standard TB Treatment to Prevent Lung Disease After Tuberculosis in Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating whether N-acetylcysteine NAC can help prevent post-tuberculosis lung disease PTLD in patients who have severe lung problems caused by pulmonary tuberculosis. The study also monitors the safety of NAC. It aims to find out if NAC improves lung function measured by FEV1% over 12 months in patients with pulmonary tuberculosis and risk factors for PTLD, and what medical issues or side effects occur during treatment. The trial compares NAC plus standard TB treatment to standard TB treatment alone. Participants will be randomly assigned to receive either NAC at a dose of 1800 mg twice daily along with standard TB treatment for the first 6 months, or standard TB treatment alone for 6 months. After the treatment period, participants will be followed for an additional 6 months. Standard TB treatment consists of fixed dose combination tablets. The trial is open-label and has parallel groups. During the 12-month study, participants will attend scheduled clinic visits for respiratory assessments, blood tests, and symptom monitoring. They will also complete quality-of-life questionnaires and provide sputum and blood samples at various times. Researchers will measure lung function, respiratory symptoms, quality of life, and laboratory markers including sputum culture and blood glutathione. Safety will be monitored through recording adverse events and liver function tests.

A Confirmatory Trial of Adjunctive NAC to Prevent Post Tuberculosis Lung Disease