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Recruiting NCT04921943

Hypertonic Saline for MAC

Phase IV Interventional Nontuberculous Mycobacterial Lung Disease Nontuberculous Mycobacterium Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypertonic saline, Azithromycin, Ethambutol, Rifampin.
Who it may be relevant to
Registry conditions: Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterium Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Culture conversion [Time frame: 12 weeks]
Secondary outcome measures (1)
  • Semi-quantitative culture results [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • NYU Langone Health — New York
  • Oregon Health & Science University — Portland
Canada · 1 center
  • University Health Network — Toronto

Identifiers

NCT: NCT04921943 · MAC-HS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗