NCT06909799

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: The Aurum Institute NPC · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Study Summary: This prospective, randomized, controlled, parallel-arm, open-label clinical trial evaluates the efficacy of N-acetylcysteine (NAC) as an adjunctive therapy for persons with pulmonary tuberculosis and risk factors for PTLD. The study aims to determine the long-term impact of NAC on lung function, respiratory symptoms, and quality of life in patients with drug-sensitive, culture-confirmed pulmonary tuberculosis (TB). Study Rationale: Pulmonary TB is a leading cause of chronic lung impairment globally. PTLD results in significant morbidity even after successful TB treatment. Prior research suggests NAC may mitigate oxidative stress and preserve lung function in TB patients. This trial seeks to confirm and expand findings from the NAC-TB sub-study of TB Sequel regarding PTLD prevention and treatment. This trial aims to provide robust evidence on the role of NAC in PTLD management, potentially informing future TB treatment guidelines.

Conditions

• Tuberculosis (TB)

Interventions

Type	Name	Description
DRUG	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.
DRUG	Standard TB treatment	Standard TB treatment will be provided as fixed dose combination tablets.

Timeline

• Start date: 2025-04-28
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-04-04
• Last updated: 2025-04-30

Locations

1 site across 1 country: The Gambia