Hypertonic Saline for MAC

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterium Infection

Intervention / Treatment
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* Drug: Hypertonic saline
* Drug: Azithromycin
* Drug: Ethambutol
* Drug: Rifampin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypertonic saline<br>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. | Drug: Hypertonic saline<br>* Nebulizing with 7% hypertonic saline twice daily for 12 weeks.<br>|
| Active Comparator: Standard of Care<br>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. | Drug: Azithromycin<br>* Standard of care<br>Drug: Ethambutol<br>* Standard of care<br>Drug: Rifampin<br>* Standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Culture conversion | At least two negative AFB cultures on different days. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semi-quantitative culture results | Evaluate acid fast bacilli (AFB) smear results to see if there is a decreased mycobacterial load (i.e. AFB smear 4+ decreasing to 3+). | 12 weeks |