Hypertonic Saline for MAC

NCT04921943 | Recruiting Phase 4 FDA Drug

• 1 other identifier: MAC-HS
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Nontuberculous Mycobacterial Lung Disease; Nontuberculous Mycobacterium Infection

Outcome Measures

Primary Outcomes (1)

• Culture conversion

  At least two negative AFB cultures on different days.

  12 weeks

Secondary Outcomes (1)

• Semi-quantitative culture results

  12 weeks

Study Arms (2)

Hypertonic saline

EXPERIMENTAL

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.

Drug: Hypertonic saline

Standard of Care

ACTIVE COMPARATOR

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.

Drug: Azithromycin; Drug: Ethambutol; Drug: Rifampin

Interventions

Hypertonic saline DRUG

Nebulizing with 7% hypertonic saline twice daily for 12 weeks.

Hypertonic saline

Azithromycin DRUG

Standard of care

Standard of Care

Ethambutol DRUG

Standard of care

Standard of Care

Rifampin DRUG

Standard of care

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any patient who is unwilling or unable to provide consent or to comply with this protocol
• Cavitary NTM disease
• Patients who are currently taking or within the prior 6 months received any of the following: bedaquiline, or any component of ATS/IDSA multi-drug recommended therapy (macrolide, ethambutol, rifampin) for MAC treatment
• Diagnosis of HIV
• Diagnosis of Cystic fibrosis
• Active pulmonary tuberculosis, fungal, or nocardial disease requiring treatment at screening
• Current use of chronic systemic corticosteroids at doses of 15 mg/day for more than 3 months
• Prior lung or other solid organ transplant

Sponsors & Collaborators

• Oregon Health and Science University: lead
• NTM Info & Research, Inc.: collaborator
• University Health Network, Toronto: collaborator
• New York University: collaborator

Study Sites (3)

NYU Langone Health

New York, New York, 10016, United States

ACTIVE NOT RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

University Health Network

Toronto, Ontario, ON M5G, Canada

RECRUITING

MeSH Terms

Conditions

Mycobacterium Infections, Nontuberculous

Interventions

Saline Solution, Hypertonic; Azithromycin; Ethambutol; Rifampin

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ethylenediamines; Diamines; Polyamines; Amines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Daniel Bouchat

CONTACT

503-494-1859; johdanie@ohsu.edu

Alyssa Schroeder

CONTACT

503-494-2136; schroeder@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: May 18, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)