NCT07647575 Hypertonic Saline Inhalation for Nontuberculous Mycobacterial Lung Disease
| NCT ID | NCT07647575 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Taipei Veterans General Hospital, Taiwan |
| Condition | Nontuberculous Mycobacterial Lung Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 262 participants |
| Start Date | 2025-10-03 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 262 participants in total. It began in 2025-10-03 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Adults aged 18 years or older. 2. 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. 3. Not receiving anti-NTM antibiotic treatment at the time of screening. 4. Able and willing to provide written informed consent. 5. Able to perform nebulized inhalation therapy using a mesh nebulizer at home. Exclusion Criteria: 1. Active tuberculosis. 2. Human immunodeficiency virus (HIV) infection. 3. Receiving active treatment for malignancy. 4. Uncontrolled asthma. 5. Frequent or clinically significant hemoptysis. 6. History of intolerance, bronchospasm, or hypersensitivity during inhalation testing with hypertonic saline. 7. Inability to prepare a mesh nebulizer or perform inhalation therapy at home. 8. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study participation.
Contact & Investigator
Sheng-Wei Pan, MD, PhD
PRINCIPAL INVESTIGATOR
Taipei Veterans General Hospital, Taiwan
Frequently Asked Questions
Who can join the NCT07647575 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nontuberculous Mycobacterial Lung Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07647575 currently recruiting?
Yes, NCT07647575 is actively recruiting participants. Contact the research team at swpan2@vghtpe.gov.tw for enrollment information.
Where is the NCT07647575 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT07647575 clinical trial?
NCT07647575 is sponsored by Taipei Veterans General Hospital, Taiwan. The principal investigator is Sheng-Wei Pan, MD, PhD at Taipei Veterans General Hospital, Taiwan. The trial plans to enroll 262 participants.