Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Radboud University Medical Center
Nijmegen, Netherlands, 6225GA
Actively Recruiting
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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