Hypertonic Saline Inhalation for Nontuberculous Mycobacterial Lung Disease

NCT07647575 | Recruiting

• 3 other identifiers: HiNTM-01114-2314-B-075 -0792025-02-019A
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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.

Conditions

Nontuberculous Mycobacterial Lung Disease; Bronchiectasis

Keywords

Hypertonic saline inhalation; Airway clearance therapy; Nontuberculous Mycobacterial Lung Disease; Bronchiectasis; Mycobacterium avium complex; Mycobacterium abscessus; Respiratory Severity Score; Nebulized Hypertonic Saline; NTM-LD

Outcome Measures

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.

  Baseline and Month 3

Secondary Outcomes (11)

• Change in Acid-Fast Bacilli (AFB) Sputum Smear Grade Over Time

  Baseline, Month 3, and Month 6

• Change in Mycobacterial Sputum Culture Status Over Time

  Baseline, Month 3, and Month 6

• Change in Radiographic Severity Score From Baseline to Month 6

  Baseline and Month 6

• Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Month 6

  Baseline and Month 6

• Change in R5-R20 Measured by Impulse Oscillometry From Baseline to Month 6

  Baseline and Month 6

Other Outcomes (3)

• Change in Chest CT Findings From Baseline to Month 6

  Baseline and Month 6

• Serum Carbohydrate Antigen 19-9 (CA19-9) Level

  Baseline, Month 3 and Month 6

• Serum Cancer Antigen 125 (CA125) Level

  Baseline, Month 3 and Month 6

Study Arms (2)

Early Hypertonic Saline Initiation

EXPERIMENTAL

Participants receive nebulized 3% hypertonic saline (5 mL once daily via mesh nebulizer) for 6 months in addition to standard clinical care. Anti-NTM antibiotic treatment may be initiated at the discretion of the treating physician according to clinical indications.

Drug: Nebulized 3% Hypertonic Saline

Delayed Hypertonic Saline Initiation

ACTIVE COMPARATOR

Participants receive nebulized normal saline (5 mL once daily via mesh nebulizer) during Months 0-3, followed by nebulized 3% hypertonic saline during Months 4-6, in addition to standard clinical care. Anti-NTM antibiotic treatment may be initiated at the discretion of the treating physician according to clinical indications.

Drug: Nebulized 3% Hypertonic Saline; Drug: Nebulized Normal Saline

Interventions

Nebulized 3% Hypertonic Saline DRUG

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.

Delayed Hypertonic Saline Initiation; Early Hypertonic Saline Initiation

Nebulized Normal Saline DRUG

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

Delayed Hypertonic Saline Initiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Active tuberculosis.
• Human immunodeficiency virus (HIV) infection.
• Receiving active treatment for malignancy.
• Uncontrolled asthma.
• Frequent or clinically significant hemoptysis.
• History of intolerance, bronchospasm, or hypersensitivity during inhalation testing with hypertonic saline.
• Inability to prepare a mesh nebulizer or perform inhalation therapy at home.
• Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study participation.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Related Publications (2)

• Huiberts A, Zweijpfenning SMH, Pennings LJ, Boeree MJ, van Ingen J, Magis-Escurra C, Hoefsloot W. Outcomes of hypertonic saline inhalation as a treatment modality in nontuberculous mycobacterial pulmonary disease. Eur Respir J. 2019 Jul 11;54(1):1802143. doi: 10.1183/13993003.02143-2018. Print 2019 Jul. No abstract available.

  PMID: 31000680 RESULT

• Daley CL, Iaccarino JM, Lange C, Cambau E, Wallace RJ Jr, Andrejak C, Bottger EC, Brozek J, Griffith DE, Guglielmetti L, Huitt GA, Knight SL, Leitman P, Marras TK, Olivier KN, Santin M, Stout JE, Tortoli E, van Ingen J, Wagner D, Winthrop KL. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline. Clin Infect Dis. 2020 Aug 14;71(4):e1-e36. doi: 10.1093/cid/ciaa241.

  PMID: 32628747 RESULT

MeSH Terms

Conditions

Bronchiectasis; Mycobacterium avium-intracellulare Infection; Mycobacterium Infections, Nontuberculous

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sheng-Wei Pan, MD, PhD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng-Wei Pan, MD, PhD

CONTACT

+886-2-28717456; swpan2@vghtpe.gov.tw

Jia-Yih Feng, MD, PhD

CONTACT

+886-2-28712121; jyfeng@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Chest Medicine, Taipei Veterans General Hospital

Model Details: Participants are randomized in a 1:1 ratio to either early initiation of 3% hypertonic saline inhalation for 6 months or delayed initiation consisting of normal saline inhalation during Months 0-3 followed by 3% hypertonic saline during Months 4-6. The primary comparison is performed at Month 3 between the two parallel groups.

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 15, 2026
• Study Start: October 3, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)