Using hypertonic saline to improve lung health in patients with M. avium complex infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University Health Network
  Toronto, Ontario, Canada Recruiting
• NYU Langone Health
  New York, New York, United States Completed
• Oregon Health & Science University
  Portland, Oregon, United States Completed

Study contacts

• Study coordinator: Daniel Bouchat
• Email: johdanie@ohsu.edu
• Phone: 503-494-1859

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.