A Confirmatory Trial of Adjunctive NAC to Prevent Post Tuberculosis Lung Disease
A Confirmatory Trial of Adjunctive N-acetylcysteine to Prevent Post Tuberculosis Lung Disease (NAC-PTLD) - A TB SEQUEL II Substudy
About This Trial
The goal of this clinical trial is to evaluate if N-acetylcysteine (NAC) works to prevent post-tuberculosis lung disease (PTLD) in patients with severe pulmonary impairment. It also aims to assess the safety of NAC. The main questions the study aims to answer are: Does NAC improve lung function (FEV1%) over 12 months in participants with pulmonary tuberculosis and baseline risk factors for PTLD? What medical issues or adverse events do participants experience while taking NAC? Researchers will compare NAC treatment to a control group to see if it can prevent PTLD when given in addition to standard TB treatment. Participants will: Take NAC (1800mg twice daily) for 6 months with standard TB treatment or receive standard TB treatment alone; Attend scheduled clinic visits for 12 months, during which they will have respiratory assessments, blood tests, and symptom monitoring; Complete quality-of-life questionnaires and provide sputum and blood samples for analysis at multiple time points.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
N-Acetyl Cysteine (NAC)
NAC will be provided as 600 mg capsules from NOW Healthgroup. Standard TB treatment will be provided as fixed dose combination tablets.
Standard TB treatment
Standard TB treatment will be provided as fixed dose combination tablets.