Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05192057

Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease

Led by Radboud University Medical Center · Updated on 2025-06-26

30

Participants Needed

1

Research Sites

227 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The SALINE trial will investigate the effect of Hypertonic Saline inhalation plus best supportive care on burden of symptoms, clearance of mycobacteria and functional capacities in participants with Mycobacterium avium complex lung disease and compare the effect to treatment with best supportive care alone.

CONDITIONS

Official Title

Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with symptomatic nodular-bronchiectatic MAC lung disease confirmed by radiography
  • At least 2 positive cultures of the same MAC species or 1 positive bronchoalveolar lavage culture
  • At least 1 positive MAC sputum culture collected within the past 4 months
  • Signed and dated informed consent
Not Eligible

You will not qualify if you...

  • Fibrocavitary MAC lung disease
  • Antimycobacterial treatment in the last 6 months
  • Previous treatment failure for MAC lung disease
  • Current clinically relevant asthma or bronchial hyperresponsiveness contraindicating HSi
  • Current use of Hypertonic Saline inhalation
  • Previous adverse reaction to Hypertonic Saline inhalation
  • Intolerance to Hypertonic Saline during screening test inhalation
  • Diagnosis of HIV
  • Diagnosis of cystic fibrosis
  • Active pulmonary malignancy or recent cancer treatment within 6 months
  • Active pulmonary tuberculosis, fungal or nocardial disease needing treatment
  • Chronic systemic corticosteroids use over 15 mg/day for more than 3 months
  • Prior lung or other solid organ transplant
  • Known or suspected current drug or alcohol abuse compromising safety or cooperation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Radboud University Medical Center

Nijmegen, Netherlands, 6225GA

Actively Recruiting

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Research Team

A

Arthur Lemson, MSc

CONTACT

W

Wouter Hoefsloot, MSc, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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