Hypertonic Saline for Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Disease
Who is this study for? Adult patients with Mycobacterial Lung Disease
What treatments are being studied? Hypertonic Saline
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The MAC-HS study is a testing whether hypertonic saline helps improve symptoms and clearance of mycobacteria in patients with M. avium complex lung infections.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• At least 2 positive MAC sputum cultures in the last 12 months with at least one AFB positive sputum obtained within 12 weeks prior to randomization
• Meet American Thoracic Society (ATS)/ Infectious Disease Society of America (IDSA) 2007 pulmonary clinical disease criteria\[1\]
• Age 18 and older
• Diagnosis of Bronchiectasis and/or bronchiectatic findings evident on chest CT report
• Ability to provide informed consent
Locations
United States
New York
NYU Langone Health
ACTIVE_NOT_RECRUITING
New York
Oregon
Oregon Health & Science University
RECRUITING
Portland
Other Locations
Canada
University Health Network
RECRUITING
Toronto
Contact Information
Primary
Daniel Bouchat
johdanie@ohsu.edu
503-494-1859
Backup
Alyssa Schroeder
schroeder@ohsu.edu
503-494-2136
Time Frame
Start Date: 2021-05-18
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 50
Treatments
Experimental: Hypertonic saline
Patients who randomize to the hypertonic saline arm will be prescribed a nebulizer device to nebulize hypertonic saline (7%) twice daily for 12 weeks. Hypertonic saline (3%) can be prescribed in the case of poor tolerability of the 7% solution.
Active_comparator: Standard of Care
Patients who randomize to the standard of care arm will receive treatment for pulmonary MAC based on the approved ATS/IDSA guidelines. Changes to standard of care regimen may be made based on the investigator's discretion.
Authors
Related Therapeutic Areas
Sponsors
Collaborators: NTM Info & Research, Inc., University Health Network, Toronto, New York University
Leads: Oregon Health and Science University