Hypertonic Saline for MAC

Oregon Health and Science University (Other)
Overall Status
CT.gov ID
NTM Info & Research, Inc. (Other), University Health Network, Toronto (Other), New York University (Other)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The MAC-HS study is an open label, randomized control trial of hypertonic saline in pulmonary

  1. 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 Design

Study Type:
Anticipated Enrollment :
50 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
Hypertonic Saline for Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Disease
Actual Study Start Date :
May 18, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Culture conversion [12 weeks]

    At least two negative AFB cultures on different days.

Secondary Outcome Measures

  1. Semi-quantitative culture results [12 weeks]

    Evaluate acid fast bacilli (AFB) smear results to see if there is a decreased mycobacterial load (i.e. AFB smear 4+ decreasing to 3+).

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016
2 Oregon Health & Science University Portland Oregon United States 97239
3 University Health Network Toronto Ontario Canada ON M5G

Sponsors and Collaborators

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


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Kevin Winthrop, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • MAC-HS
First Posted:
Jun 10, 2021
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2022