이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Hypertonic Saline Inhalation for Nontuberculous Mycobacterial Lung Disease (HiNTM)

2026년 6월 10일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

262

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 대만
      • Taipei, 대만, 11217
        • 모병
        • Taipei Veterans General Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 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.
활성 비교기: 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.
의약품: 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.
의약품: Nebulized Normal Saline
Nebulized 0.9% normal saline, 5 mL once daily via mesh nebulizer during Months 0-3 in the delayed-initiation arm.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Total Respiratory Severity Score (RSS) From Baseline to Month 3
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Acid-Fast Bacilli (AFB) Sputum Smear Grade Over Time
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Up to Month 6
Proportion of Participants Requiring Anti-NTM Antibiotic Treatment
Up to Month 6
Adverse Events
기간: 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
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Change in Chest CT Findings From Baseline to Month 6
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Taipei Veterans General Hospital, Taiwan

협력자

National Science and Technology Council, Taiwan

수사관

  • 수석 연구원: Sheng-Wei Pan, MD, PhD, Taipei Veterans General Hospital, Taiwan

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 10월 3일

기본 완료 (추정된)

2028년 4월 30일

연구 완료 (추정된)

2028년 7월 31일

연구 등록 날짜

최초 제출

2026년 6월 6일

QC 기준을 충족하는 최초 제출

2026년 6월 10일

처음 게시됨 (실제)

2026년 6월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 10일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • HiNTM-01
  • 114-2314-B-075 -079 (기타 보조금/기금 번호: National Science and Technology Council, Taiwan)
  • 2025-02-019A (기타 식별자: Taipei Veterans General Hospital)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Nebulized 3% Hypertonic Saline에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Burkina Faso

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다