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Hypertonic Saline Inhalation for Nontuberculous Mycobacterial Lung Disease (HiNTM)

10 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

262

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Taiwan
      • Taipei, Taiwan, 11217
        • Reclutamento
        • Taipei Veterans General Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Total Respiratory Severity Score (RSS) From Baseline to Month 3
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Acid-Fast Bacilli (AFB) Sputum Smear Grade Over Time
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to Month 6
Proportion of Participants Requiring Anti-NTM Antibiotic Treatment
Up to Month 6
Adverse Events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Chest CT Findings From Baseline to Month 6
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Taipei Veterans General Hospital, Taiwan

Collaboratori

National Science and Technology Council, Taiwan

Investigatori

  • Investigatore principale: Sheng-Wei Pan, MD, PhD, Taipei Veterans General Hospital, Taiwan

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 ottobre 2025

Completamento primario (Stimato)

30 aprile 2028

Completamento dello studio (Stimato)

31 luglio 2028

Date di iscrizione allo studio

Primo inviato

6 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2026

Primo Inserito (Effettivo)

15 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HiNTM-01
  • 114-2314-B-075 -079 (Altro numero di sovvenzione/finanziamento: National Science and Technology Council, Taiwan)
  • 2025-02-019A (Altro identificatore: Taipei Veterans General Hospital)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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