Using hypertonic saline to improve lung health in patients with M. avium complex infections
Hypertonic Saline for Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Disease
This study is testing if inhaling hypertonic saline can help people with lung infections from the M. avium complex feel better and clear the infection more effectively than standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 3 sites (New York, New York and 2 other locations) |
| Trial ID | NCT04921943 on ClinicalTrials.gov |
What this trial studies
The MAC-HS study is an open-label, randomized control trial designed to evaluate the effectiveness of inhaled hypertonic saline in patients suffering from pulmonary infections caused by the M. avium complex. Participants will be randomly assigned to receive either hypertonic saline or standard care for a duration of 12 weeks. The treatment group will inhale hypertonic saline twice daily while continuing other airway clearance methods and may receive antibiotics for exacerbations. The study aims to assess symptom improvement and mycobacterial clearance in these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of bronchiectasis and at least two positive MAC sputum cultures in the past year.
Not a fit: Patients with cavitary NTM disease, active pulmonary tuberculosis, or those currently on specific MAC treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients with M. avium complex lung infections.
How similar studies have performed: While the use of hypertonic saline in other respiratory conditions has shown promise, this specific application for M. avium complex infections is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York and 2 other locations
- NYU Langone Health — New York, New York, United States (Active_not_recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Daniel Bouchat
- Email: johdanie@ohsu.edu
- Phone: 503-494-1859
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.