Hypertonic saline inhalation for NTM lung disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial assigns adults with NTM-LD to either early use of inhaled 3% hypertonic saline for 6 months or a delayed start with normal saline for 3 months followed by hypertonic saline for 3 months. The study looks at symptom improvement as the primary outcome at 3 months, with secondary outcomes including microbiological results, imaging changes, inflammatory markers, and small airway function. All participants undergo a supervised inhalation tolerance test with salbutamol before randomization to ensure safety. Interventions consist of nebulized 3% hypertonic saline or nebulized normal saline, delivered at home via mesh nebulizers. Participants are adults diagnosed by standard criteria and not on anti-NTM antibiotics at screening.

Why it matters

Who can join: the full rules

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.

Where it's running

• Taipei Veterans General Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Principal investigator: Sheng-Wei Pan, MD, PhD — Taipei Veterans General Hospital, Taiwan
• Study coordinator: Sheng-Wei Pan, MD, PhD
• Email: swpan2@vghtpe.gov.tw
• Phone: +886-2-28717456

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Chronic Respiratory Disease Participant Engagement

  This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.

  Recruiting Richmond Pharmacology Limited · London · NCT07924462

• Breathlessness in respiratory diseases: who feels it and why

  This study tests how physiology, psychology, function, and breathing patterns relate to breathlessness in people with respiratory conditions compared with healthy controls.

  Recruiting University Hospitals, Leicester · Leicester, Leicestershire · NCT07648082

• Azithromycin added to usual care to see if it lowers bronchiectasis flare-ups

  This trial tests whether taking azithromycin daily for a year reduces bronchiectasis-related flare-ups in adults with non-cystic fibrosis bronchiectasis.

  Recruiting Phase 4 Assiut University · Asyut · NCT07608328

• Bronchiectasis Phenotype Identification Model for Adults

  This study tests a baseline classifier to categorize adults with non-cystic fibrosis bronchiectasis into phenotype groups using data collected over time.

  Recruiting Assiut University · Asyut, Assiut Egypt · NCT07599969

• BASE: Aiming to test a simple, objective way to gauge bronchiectasis severity and predict flare-ups

  This study tests a new BASE framework to classify how severe non-cystic fibrosis bronchiectasis is right now and see if it can predict 12 months of worsening or flare-ups.

  Recruiting Assiut University · Asyut, Asyut Egypt · NCT07599839

• Immune status and disease control in airway inflammatory diseases

  This project will test whether specific blood immune cell patterns relate to disease control in adults with asthma, COPD, bronchiectasis, or obstructive sleep apnea by comparing them with healthy volunteers.

  Recruiting First Affiliated Hospital of Ningbo University · Ningbo, Zhejiang · NCT07493629

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.