Hypertonic Saline for MAC

Sponsor

Oregon Health and Science University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04921943

Collaborator

NTM Info & Research, Inc. (Other), University Health Network, Toronto (Other), New York University (Other)

Enrollment

Locations

Arms

31.4

Anticipated Duration (Months)

16.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nontuberculous Mycobacterial Lung Disease Nontuberculous Mycobacterium Infection	Drug: Hypertonic saline Drug: Azithromycin Drug: Ethambutol Drug: Rifampin	Phase 4

Detailed Description

The MAC-HS study is an open label, randomized control trial of hypertonic saline in pulmonary

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 18, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Hypertonic saline Nebulizing with 7% hypertonic saline twice daily for 12 weeks.
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.	Drug: Azithromycin Standard of care Drug: Ethambutol Standard of care Drug: Rifampin Standard of care

Arm

Intervention/Treatment

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.

Drug: Hypertonic saline

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

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.

Drug: Azithromycin

Standard of care

Drug: Ethambutol

Standard of care

Drug: Rifampin

Standard of care

Outcome Measures

Primary Outcome Measures

Culture conversion [12 weeks]
At least two negative AFB cultures on different days.

Secondary Outcome Measures

Semi-quantitative culture results [12 weeks]
Evaluate acid fast bacilli (AFB) smear results to see if there is a decreased mycobacterial load (i.e. AFB smear 4+ decreasing to 3+).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016
2	Oregon Health & Science University	Portland	Oregon	United States	97239
3	University Health Network	Toronto	Ontario	Canada	ON M5G