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New treatment option for Nontuberculous Mycobacterial Lung Disease
Official title Hypertonic Saline for MAC
ClinicalTrials.gov ID: NCT04921943
What this study is testing
What is Hypertonic saline?
Hypertonic saline is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for nontuberculous mycobacterial lung disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Diagnosis of HIV
- Diagnosis of Cystic fibrosis
- Active pulmonary tuberculosis, fungal, or nocardial disease requiring treatment at screening
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Portland, Oregon, United States
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Portland, Oregon, United States; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.