Hypertonic Saline Inhalation for Nontuberculous Mycobacterial Lung Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Nebulized 3% Hypertonic Saline: Nebulized 3% hypertonic saline, 5 mL once daily via mesh nebulizer. Administered during Months 0-6 in the early-initiation arm and during Months 4-6 in the delayed-initiation arm after completion of the Month 3 assessment.

Nebulized Normal Saline: Nebulized 0.9% normal saline, 5 mL once daily via mesh nebulizer during Months 0-3 in the delayed-initiation arm.

Study summary

This multicenter randomized controlled trial evaluates the clinical and microbiological effects of inhaled 3% hypertonic saline in treatment-naïve patients with nontuberculous mycobacterial lung disease (NTM-LD). Participants are randomized in a 1:1 ratio to either early initiation of 3% hypertonic saline for 6 months or delayed initiation consisting of normal saline inhalation during the first 3 months followed by 3% hypertonic saline during the subsequent 3 months.

The primary objective is to compare respiratory symptom improvement between hypertonic saline and normal saline at Month 3. Secondary objectives include evaluating sputum microbiological outcomes, radiographic changes, inflammatory markers, small airway function, treatment initiation, safety, and within-participant changes before and after switching from normal saline to hypertonic saline in the delayed-initiation arm.

The first participant was enrolled on October 3, 2025.

Eligibility

Primary outcome measure(s)

• Change in Total Respiratory Severity Score (RSS) From Baseline to Month 3 — Baseline and Month 3
  Total Respiratory Severity Score (RSS) ranges from 0 to 60 and is calculated from six visual analog scales evaluating cough, sputum production, dyspnea, fatigue, sleep disturbance, and overall respiratory symptoms. Higher scores indicate worse symptoms.

Trial sites (1)

More Taipei Veterans General Hospital, Taiwan trials in Taiwan

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