Hypertonic Saline Inhalation for Nontuberculous Mycobacterial Lung Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaipei Veterans General Hospital, Taiwan
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Diagnosis of nontuberculous mycobacterial lung disease (NTM-LD) according to ATS/ERS/ESCMID/IDSA diagnostic criteria, including compatible clinical symptoms, radiographic findings, and microbiological evidence.
Not receiving anti-NTM antibiotic treatment at the time of screening.
Able and willing to provide written informed consent.
Disqualifiers
Active tuberculosis.
Human immunodeficiency virus (HIV) infection.
Receiving active treatment for malignancy.
Uncontrolled asthma.
Trial design
Design model
Parallel
Treatments tested in this trial
Nebulized 3% Hypertonic Saline
DrugNebulized 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
DrugNebulized 0.9% normal saline, 5 mL once daily via mesh nebulizer during Months 0-3 in the delayed-initiation arm.
Treatment groups
262 Participants
are divided into 2 treatment groupsGroup A: Early Hypertonic Saline InitiationExperimental treatment 1 intervention
Group B: Delayed Hypertonic Saline InitiationActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in Total Respiratory Severity Score (RSS) From Baseline to 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.
Time frame
Baseline and Month 3Secondary outcomes
1
Change in Acid-Fast Bacilli (AFB) Sputum Smear Grade Over Time
AFB sputum smear grade assessed using standard semi-quantitative microscopy (negative, scanty, 1+, 2+, 3+, or 4+) at Baseline, Month 3, and Month 6. Changes in smear grade and the proportion of participants achieving smear negativity will be evaluated.
Time frame
Baseline, Month 3, and Month 62
Change in Mycobacterial Sputum Culture Status Over Time
Sputum culture status assessed as positive or negative for nontuberculous mycobacteria using standard mycobacterial culture methods at Baseline, Month 3, and Month 6. Culture conversion is defined as a change from positive at baseline to negative at follow-up assessments.
Time frame
Baseline, Month 3, and Month 63
Change in Radiographic Severity Score From Baseline to Month 6
Radiographic Severity Score assessed using a chest radiographic scoring system. Each lung is divided into three areas. The extent of infiltration in each area is scored from 0 to 3, resulting in a total score ranging from 0 to 18. Higher scores indicate more extensive pulmonary disease.
Time frame
Baseline and Month 64
Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Month 6
Erythrocyte sedimentation rate (ESR) will be measured using a standard clinical laboratory assay. Higher values indicate greater systemic inflammation.
Time frame
Baseline and Month 6Other outcomes
1
Change in Chest CT Findings From Baseline to Month 6
Chest CT findings including bronchiectasis, bronchiolitis (tree-in-bud pattern), nodules, consolidation, and cavitary lesions will be evaluated at baseline and Month 6 by comparison of serial CT scans.
Time frame
Baseline and Month 62
Serum Carbohydrate Antigen 19-9 (CA19-9) Level
Change in serum carbohydrate antigen 19-9 (CA19-9) concentration from baseline to Months 3 and 6. CA19-9 will be measured using a standard clinical laboratory assay. Higher levels may reflect greater airway inflammation and disease burden in nontuberculous mycobacterial lung disease.
Time frame
Baseline, Month 3 and Month 63
Serum Cancer Antigen 125 (CA125) Level
Change in serum cancer antigen 125 (CA125) concentration from baseline to Months 3 and 6. CA125 will be measured using a standard clinical laboratory assay. Higher levels may reflect greater pulmonary disease activity and extent of bronchiectatic involvement.
Time frame
Baseline, Month 3 and Month 6Sponsors and contacts
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Taipei Veterans General Hospital, Taiwan
Lead sponsor
National Science and Technology Council, Taiwan
Collaborator
Source ClinicalTrials.gov