Actively Recruiting
Hypertonic Saline for Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Disease
Led by Oregon Health and Science University · Updated on 2025-08-15
50
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Oregon Health and Science University
Lead Sponsor
N
NTM Info & Research, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether inhaled hypertonic saline can improve symptoms and help clear Mycobacterium avium complex (MAC) infections in the lungs of adults diagnosed with pulmonary MAC disease. This open-label, randomized controlled trial compares hypertonic saline treatment to standard care, aiming to better understand its effects on lung infection management. The study is sponsored by Oregon Health and Science University and follows guidelines from the American Thoracic Society and Infectious Disease Society of America. Participants will be randomly assigned to one of two groups for 12 weeks: one group will inhale 7% hypertonic saline twice daily using a nebulizer device, with a 3% concentration option if the stronger dose is not tolerated. The other group will receive standard treatment based on ATS/IDSA guidelines, including drugs like azithromycin, ethambutol, and rifampin. Participants in both groups may continue other airway clearance techniques and receive antibiotics for exacerbations as needed. During the study, participants will have sputum samples collected to measure culture conversion at 12 weeks, along with semi-quantitative culture assessments. Safety and any adverse events will be monitored throughout the trial. Even if disease worsens, participants will complete the 12-week study visit. The total participation time is 12 weeks, during which researchers will assess how well the treatments help clear the lung infection.
CONDITIONS
Brief Title
Hypertonic Saline for MAC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 2 positive MAC sputum cultures in the last 12 months with at least one acid-fast bacilli positive sputum within 12 weeks prior to randomization
- Meet American Thoracic Society (ATS)/ Infectious Disease Society of America (IDSA) 2007 pulmonary clinical disease criteria
- Age 18 years or older
- Diagnosis of bronchiectasis or bronchiectatic findings on chest CT
- Ability to provide informed consent
You will not qualify if you...
- Unable or unwilling to provide consent or comply with the protocol
- Cavitary nontuberculous mycobacterial disease
- Use of bedaquiline or ATS/IDSA recommended multi-drug therapy components for MAC in the past 6 months
- Diagnosis of HIV
- Diagnosis of cystic fibrosis
- Active pulmonary tuberculosis, fungal, or nocardial infection requiring treatment at screening
- Use of chronic systemic corticosteroids at doses of 15 mg/day or more for over 3 months
- Prior lung or other solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either inhaled hypertonic saline twice daily for 12 weeks or standard of care treatment according to ATS/IDSA guidelines for pulmonary MAC disease.
Visits as scheduled during the 12-week treatment period
Trial Site Locations
Total: 3 locations
1
NYU Langone Health
New York, New York, United States, 10016
Active, Not Recruiting
2
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
3
University Health Network
Toronto, Ontario, Canada, ON M5G
Actively Recruiting
Research Team
D
Daniel Bouchat
A
Alyssa Schroeder
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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