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RecruitingPhase 4NCT04921943

Hypertonic Saline for MAC

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

Sponsor

Oregon Health and Science University

Enrollment

50 participants

Start Date

May 18, 2021

Study Type

INTERVENTIONAL

Conditions

Nontuberculous Mycobacterium InfectionNontuberculous Mycobacterial Lung Disease

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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
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Interventions

DRUGHypertonic saline

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

DRUGAzithromycin

Standard of care

DRUGEthambutol

Standard of care

DRUGRifampin

Standard of care

Locations(3)

NYU Langone Health

New York, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

University Health Network

Toronto, Ontario, Canada

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NCT04921943

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