Hypertonic Saline for MAC

Nontuberculous Mycobacterium Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04921943
• Other study ID #: MAC-HS
• Status: Recruiting
• Phase: Phase 4
• Start date: May 18, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: Oregon Health and Science University
• Contact: Daniel Bouchat
• Phone: 503-494-1859
• Email: johdanie[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Mycobacterium Infections
• Mycobacterium Infections, Nontuberculous
• Nontuberculous Mycobacterial Lung Disease
• Nontuberculous Mycobacterium Infection

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario
United States	NYU Langone Health	New York	New York
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Oregon Health and Science University	New York University, NTM Info & Research, Inc., University Health Network, Toronto

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Culture conversion	At least two negative AFB cultures on different days.	12 weeks
Secondary	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