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

Study acronym: NAC-PTLD
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 1, 2025 to Apr 28, 2025
    v3
  2. Interventions: N-Acetyl Cysteine (NAC) (Drug) to N-Acetyl Cysteine (NAC) (Drug), Standard TB treatment (Drug)v2 Show 4 more changesShow less
    • Eligibility criteria shortened, about 19 words
    • Secondary endpoints: 14 to 13
    • Study description expanded, about 7 words
    • Study title shortened, about 2 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06909799
Lead Sponsor The Aurum Institute NPC
Collaborators: Ludwig-Maximilians - University of Munich, Research Center Borstel
Conditions
(from sponsor)		 Tuberculosis (TB)
Related terms Tuberculosis
Enrollment 242 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov