Clinical trial NCT04921943: Hypertonic Saline for MAC
Official title: Hypertonic Saline for Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Nontuberculous Mycobacterial Lung Disease
Nontuberculous Mycobacterium Infection
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: NTM Info & Research, Inc.
name: University Health Network, Toronto
name: New York University
First posted: 2021-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Culture conversion
timeFrame: 12 weeks
Secondary outcomes:
measure: Semi-quantitative culture results
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References: