Nontuberculous Mycobacterial Lung DiseasePhase 4NCT04921943
Hypertonic Saline for MAC
A Phase 4 study testing Hypertonic saline, Azithromycin and Ethambutol in people with Nontuberculous Mycobacterial Lung Disease and Nontuberculous Mycobacterium Infection, run by Oregon Health and Science University at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterium Infection
- What is being tested?
- Hypertonic saline, Azithromycin and Ethambutol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 18 May 2021to 20 Jan 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites
- Completed
NYU Langone Health
New York, New York, 10016
- Completed
Oregon Health & Science University
Portland, Oregon, 97239
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, ON M5G
Matty Mehrabi, 416-603-5726, Matty.Mehrabi@uhn.ca
Theodore Marras, MD
About this study
Official title: Hypertonic Saline for Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Disease
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.
Read the detailed 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.
- Being tested
- Hypertonic saline, Azithromycin, Ethambutol, Rifampin
- Medical subject headings
- Mycobacterium Infections, Nontuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic salineDrug
Nebulizing with 7% hypertonic saline twice daily for 12 weeks.
AzithromycinDrug
Standard of care
EthambutolDrug
Standard of care
RifampinDrug
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic saline | Experimental | 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. Receives: Drug: Hypertonic saline |
| Standard of Care | Active comparator | 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. Receives: Drug: Azithromycin; Drug: Ethambutol; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Culture conversion
At least two negative AFB cultures on different days.
Measured: 12 weeks
Secondary outcomes (1)
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+).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start18 May 2021
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nontuberculous Mycobacterial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- NTM Info & Research, Inc., University Health Network, Toronto, New York University
- Responsible party
- Principal investigator, Kevin Winthrop, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921943
- Sponsor's protocol ID
- MAC-HS
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No