Hypertonic Saline for MAC

Hypertonic Saline for Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Nontuberculous Mycobacterial Lung Disease; Nontuberculous Mycobacterium Infection
• Intervention / Treatment: Drug: Hypertonic saline; Drug: Azithromycin; Drug: Ethambutol; Drug: Rifampin

Detailed Description

The MAC-HS study is an open label, randomized control trial of hypertonic saline in pulmonary M. avium complex patients. Eligible patients who consent to participate will be randomized 1:1 to hypertonic saline or standard of care for 12 weeks. All patients in the treatment group will take inhaled hypertonic saline twice daily for 12 weeks. Patients may continue with other airway clearance methods (i.e. flutter, acapella valve, aerobika, postural drainage, huff cough, percussion). Patients may also be treated with antibiotics targeted at other pathogens if an exacerbation occurs. Patients may also be actively treated with inhaled corticosteroid at the time of enrollment, with dosing adjustments during the trial discouraged. Patients with disease progression at any time can be discontinued from the study treatment and treated according to ATS/IDSA guidelines at the discretion of the primary investigator. However, such patients will still complete the 12 week final visit, sputum collection and AE assessment.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Daniel Bouchat; Phone Number: 503-494-1859; Email: johdanie@ohsu.edu
• Study Contact Backup: Name: Alyssa Schroeder; Phone Number: 503-494-2136; Email: schroeder@ohsu.edu

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, ON M5G
      • Recruiting
      • University Health Network
      • Contact: Matty Mehrabi; Phone Number: 416-603-5726; Email: Matty.Mehrabi@uhn.ca
      • Principal Investigator: Theodore Marras, MD
• United States
  • New York
    • New York, New York, United States, 10016
      • Active, not recruiting
      • NYU Langone Health
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Principal Investigator: Kevin L Winthrop, MD, MPH
      • Contact: Alyssa Schroeder; Phone Number: 503-494-2136; Email: schroeder@ohsu.edu
      • Contact: Daniel Bouchat; Phone Number: (503) 494-2568; Email: johdanie@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Hypertonic saline; Nebulizing with 7% hypertonic saline twice daily for 12 weeks.
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.	Drug: Azithromycin; Standard of care; Drug: Ethambutol; Standard of care; Drug: Rifampin; Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Culture conversion	At least two negative AFB cultures on different days.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semi-quantitative culture results	Evaluate acid fast bacilli (AFB) smear results to see if there is a decreased mycobacterial load (i.e. AFB smear 4+ decreasing to 3+).	12 weeks

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: University Health Network, Toronto; New York University; NTM Info & Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Lung Diseases; Mycobacterium Infections; Mycobacterium Infections, Nontuberculous; Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antibiotics, Antitubercular; Antitubercular Agents; Leprostatic Agents; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Cytochrome P-450 CYP3A Inducers; Azithromycin; Rifampin; Ethambutol
• Other Study ID Numbers: MAC-HS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No