Recruiting

Hypertonic Saline

Sponsor:

Oregon Health and Science University

Code:

NCT04921943

Conditions

Nontuberculous Mycobacterial Lung Disease

Nontuberculous Mycobacterium Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypertonic saline

Azithromycin

Ethambutol

Rifampin

Study Details

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

Study ID

NCT04921943

Start date

May 18, 2021

Status verified date

Aug, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Hypertonic saline

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

Azithromycin

Standard of care

Ethambutol

Standard of care

Rifampin

Standard of care

Primary outcome measure

  • Culture conversion [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Daniel Bouchat

503-494-1859johdanie@ohsu.edu

Alyssa Schroeder

503-494-2136schroeder@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Alyssa Schroeder

503-494-2136schroeder@ohsu.edu

Daniel Bouchat

(503) 494-2568johdanie@ohsu.edu

Principal Investigator:

Kevin L Winthrop, MD, MPH

University Health Network

Recruiting

Toronto, Ontario, Canada, ON M5G

Contacts

Matty Mehrabi

416-603-5726Matty.Mehrabi@uhn.ca

Principal Investigator:

Theodore Marras, MD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Aug 15, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-08-15.