Hypertonic Saline for MAC

Last updated: August 12, 2025
Sponsor: Oregon Health and Science University
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Azithromycin

Hypertonic saline

Rifampin

Clinical Study ID

NCT04921943
MAC-HS
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • At least 2 positive MAC sputum cultures in the last 12 months with at least one AFBpositive 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 CTreport

  • Ability to provide informed consent

Exclusion

Exclusion Criteria:

  • Any patient who is unwilling or unable to provide consent or to comply with thisprotocol

  • Cavitary NTM disease

  • Patients who are currently taking or within the prior 6 months received any of thefollowing: 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 atscreening

  • 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 Design

Total Participants: 50
Treatment Group(s): 4
Primary Treatment: Azithromycin
Phase: 4
Study Start date:
May 18, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • University Health Network

    Toronto, Ontario ON M5G
    Canada

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

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