Hypertonic Saline Inhalation for Nontuberculous Mycobacterial Lung Disease
Key facts
- Where
- Taipei, TaiwanSee the site
Where in Taiwan
- Taipei Veterans General HospitalTaipei, TaiwanContact: Sheng-Wei Pan, MD, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Taipei Veterans General Hospital, Taiwan
- Trial code
- NCT07647575
- Record updated
- 15 June 2026
- Original description
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.Read full original descriptionShow less
A Randomized Controlled Trial of Early Versus Delayed Hypertonic Saline Inhalation in Treatment-Naïve Nontuberculous Mycobacterial Lung Disease
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.
Inclusion: 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; Able to perform nebulized inhalation therapy using a mesh nebulizer at home.
Exclusion: Receiving active treatment for malignancy; Inability to prepare a mesh nebulizer or perform inhalation therapy at home; Active tuberculosis; Human immunodeficiency virus (HIV) infection; History of intolerance, bronchospasm, or hypersensitivity during inhalation testing with hypertonic saline; Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study participation; Uncontrolled asthma; Frequent or clinically significant hemoptysis.