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Hypertonic Saline Inhalation for Nontuberculous Mycobacterial Lung Disease (HiNTM)

10 de junio de 2026 actualizado por: Sheng-Wei Pan, Taipei Veterans General Hospital, Taiwan

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Nontuberculous mycobacterial lung disease (NTM-LD) is a chronic pulmonary infection that frequently progresses despite conservative management. Because prolonged multidrug antibiotic therapy is associated with substantial treatment burden, potential toxicity, and variable effectiveness, additional non-antibiotic treatment strategies are needed, particularly for patients who defer, cannot tolerate, or are not yet indicated for antibiotic treatment.

Hypertonic saline inhalation facilitates airway clearance and sputum removal and has been increasingly used as an adjunctive treatment in specialized NTM centers. However, prospective randomized data remain limited, particularly in Asian populations.

This multicenter randomized controlled trial investigates whether early initiation of inhaled 3% hypertonic saline improves respiratory symptoms and microbiological outcomes compared with delayed initiation.

To ensure treatment safety, all participants undergo a supervised inhalation tolerance assessment before randomization. During this assessment, inhaled salbutamol (Ventolin) premedication is administered, followed by inhalation of 3% hypertonic saline. Participants demonstrating clinically significant intolerance, severe bronchospasm, or other safety concerns are excluded from study treatment.

Following successful completion of the tolerance assessment, participants are randomized to one of two groups.

The early-initiation group receives inhaled 3% hypertonic saline for 6 months. The delayed-initiation group receives inhaled normal saline during Months 0-3, followed by inhaled 3% hypertonic saline during Months 4-6.

The primary randomized comparison is performed at Month 3 between participants receiving hypertonic saline and those receiving normal saline. Additional analyses evaluate within-participant changes in the delayed-initiation arm before and after switching from normal saline to hypertonic saline.

Throughout the study, participants continue routine clinical care. Initiation of anti-NTM antibiotic treatment remains at the discretion of the treating physician.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

262

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Sheng-Wei Pan, MD, PhD
  • Número de teléfono: +886-2-28717456
  • Correo electrónico: swpan2@vghtpe.gov.tw

Copia de seguridad de contactos de estudio

  • Nombre: Jia-Yih Feng, MD, PhD
  • Número de teléfono: +886-2-28712121
  • Correo electrónico: jyfeng@vghtpe.gov.tw

Ubicaciones de estudio

  • Taiwán
      • Taipei, Taiwán, 11217
        • Reclutamiento
        • Taipei Veterans General Hospital
        • Contacto:
          • Sheng-Wei Pan, MD, PhD
          • Número de teléfono: +886-2-28757456
          • Correo electrónico: swpan2@vghtpe.gov.tw

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Early Hypertonic Saline Initiation
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.
Droga: Nebulized 3% Hypertonic Saline
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.
Comparador activo: Delayed Hypertonic Saline Initiation
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.
Droga: Nebulized 3% Hypertonic Saline
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.
Droga: Nebulized Normal Saline
Nebulized 0.9% normal saline, 5 mL once daily via mesh nebulizer during Months 0-3 in the delayed-initiation arm.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Total Respiratory Severity Score (RSS) From Baseline to Month 3
Periodo de tiempo: Baseline and 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Acid-Fast Bacilli (AFB) Sputum Smear Grade Over Time
Periodo de tiempo: Baseline, Month 3, and Month 6
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.
Baseline, Month 3, and Month 6
Change in Mycobacterial Sputum Culture Status Over Time
Periodo de tiempo: Baseline, Month 3, and Month 6
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.
Baseline, Month 3, and Month 6
Change in Radiographic Severity Score From Baseline to Month 6
Periodo de tiempo: Baseline and 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.
Baseline and Month 6
Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Month 6
Periodo de tiempo: Baseline and Month 6
Erythrocyte sedimentation rate (ESR) will be measured using a standard clinical laboratory assay. Higher values indicate greater systemic inflammation.
Baseline and Month 6
Change in R5-R20 Measured by Impulse Oscillometry From Baseline to Month 6
Periodo de tiempo: Baseline and Month 6
R5-R20 measured by impulse oscillometry (IOS). R5 represents total airway resistance and R20 represents central airway resistance. The difference between R5 and R20 (R5-R20) reflects small airway dysfunction. Higher values indicate greater small airway impairment.
Baseline and Month 6
Change in Post-Bronchodilator FEV1 (% Predicted) From Baseline to Month 6
Periodo de tiempo: Baseline and Month 6
Post-bronchodilator forced expiratory volume in one second (FEV1), expressed as percent predicted, measured using standardized spirometry according to ATS/ERS recommendations. Higher values indicate better lung function.
Baseline and Month 6
Anti-NTM Treatment Initiation
Periodo de tiempo: Up to Month 6
Proportion of Participants Requiring Anti-NTM Antibiotic Treatment
Up to Month 6
Adverse Events
Periodo de tiempo: Up to Month 6
Incidence of Adverse Events Related to Hypertonic Saline Inhalation
Up to Month 6
Within-Participant Change in Respiratory Severity Score During Normal Saline and Hypertonic Saline Treatment Periods in the Delayed-Initiation Arm
Periodo de tiempo: Baseline to Month 6
Comparison of RSS change during Months 0-3 while receiving nebulized normal saline and during Months 4-6 while receiving nebulized 3% hypertonic saline in participants assigned to the delayed-initiation arm.
Baseline to Month 6
Change in Respiratory Severity Score From Month 3 to Month 6 in the Early-Initiation Arm
Periodo de tiempo: Month 3 and Month 6
Evaluation of continued symptom improvement after the initial 3 months of hypertonic saline treatment.
Month 3 and Month 6
Change in Total RSS at Month 6
Periodo de tiempo: Baseline and Month 6
Total 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 6

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Chest CT Findings From Baseline to Month 6
Periodo de tiempo: Baseline and 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.
Baseline and Month 6
Serum Carbohydrate Antigen 19-9 (CA19-9) Level
Periodo de tiempo: Baseline, Month 3 and Month 6
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.
Baseline, Month 3 and Month 6
Serum Cancer Antigen 125 (CA125) Level
Periodo de tiempo: Baseline, Month 3 and Month 6
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.
Baseline, Month 3 and Month 6

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Taipei Veterans General Hospital, Taiwan

Colaboradores

National Science and Technology Council, Taiwan

Investigadores

  • Investigador principal: Sheng-Wei Pan, MD, PhD, Taipei Veterans General Hospital, Taiwan

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

3 de octubre de 2025

Finalización primaria (Estimado)

30 de abril de 2028

Finalización del estudio (Estimado)

31 de julio de 2028

Fechas de registro del estudio

Enviado por primera vez

6 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de junio de 2026

Publicado por primera vez (Actual)

15 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HiNTM-01
  • 114-2314-B-075 -079 (Otro número de subvención/financiamiento: National Science and Technology Council, Taiwan)
  • 2025-02-019A (Otro identificador: Taipei Veterans General Hospital)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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