Trials / Recruiting
RecruitingNCT04921943
Hypertonic Saline for MAC
Hypertonic Saline for Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Disease
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Oregon Health and Science University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hypertonic saline | Nebulizing with 7% hypertonic saline twice daily for 12 weeks. |
| DRUG | Azithromycin | Standard of care |
| DRUG | Ethambutol | Standard of care |
| DRUG | Rifampin | Standard of care |
Timeline
- Start date
- 2021-05-18
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2021-06-10
- Last updated
- 2025-08-15
Locations
3 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04921943. Inclusion in this directory is not an endorsement.