Hypertonic Saline for MAC

Part of paid clinical trials in New York, New York.

Sponsor
Oregon Health and Science University
Study ID
NCT04921943
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Nontuberculous Mycobacterial Lung Disease
  • Nontuberculous Mycobacterium Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hypertonic saline — DRUG
    Nebulizing with 7% hypertonic saline twice daily for 12 weeks.
  • Azithromycin — DRUG
    Standard of care
  • Ethambutol — DRUG
    Standard of care
  • Rifampin — DRUG
    Standard of care

Study Details

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.

Key Dates

Start date
May 18, 2021
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Culture conversion [ Time Frame: 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-
Oregon Health & Science UniversityPortlandOregon97239
Alyssa Schroeder
[email protected]
503-494-2136
Daniel Bouchat
[email protected]
(503) 494-2568
Kevin L Winthrop, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
NYU Langone Health· New York, NYOregon Health & Science University· Portland, OR

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