50 Participants Needed

Hypertonic Saline for Nontuberculous Mycobacterial Lung Disease

Recruiting at 2 trial locations
SS
HM
DB
KL
Overseen ByKevin L Winthrop, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Oregon Health and Science University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether inhaling a saltwater solution can help patients with a specific lung infection by making it easier to clear mucus from their lungs. Saltwater solutions have been used to improve mucus clearance in conditions like cystic fibrosis and chronic bronchitis.

Will I have to stop taking my current medications?

The trial requires that you have not taken certain medications for MAC treatment, like bedaquiline or a combination of macrolide, ethambutol, and rifampin, in the past 6 months. If you are currently on these medications, you would need to stop them to participate.

Is hypertonic saline safe for treating nontuberculous mycobacterial lung disease?

The safety of hypertonic saline specifically for nontuberculous mycobacterial lung disease isn't directly addressed in the provided studies. However, some antibiotics like rifabutin, when used in combination with others, have shown adverse effects such as severe neutropenia (low white blood cell count) and gastrointestinal symptoms, indicating the importance of monitoring for side effects during treatment.12345

What makes the drug combination of Azithromycin, Ethambutol, Hypertonic Saline, and Rifampin unique for treating nontuberculous mycobacterial lung disease?

This drug combination is unique because it includes hypertonic saline, which is not typically used in standard treatments for nontuberculous mycobacterial lung disease. Hypertonic saline may help clear mucus from the lungs, potentially enhancing the effectiveness of the antibiotics Azithromycin, Ethambutol, and Rifampin, which are known to be active against various mycobacterial infections.12678

What data supports the effectiveness of the drugs used in the treatment for Nontuberculous Mycobacterial Lung Disease?

Research shows that ethambutol is effective in reducing mycobacterial levels in patients with Mycobacterium avium complex infections, and it is often used in combination with other drugs like rifampin and azithromycin to treat similar infections.125910

Are You a Good Fit for This Trial?

This trial is for adults over 18 with M. avium complex lung infections who meet specific lung disease criteria and have had at least two positive MAC sputum cultures in the past year. It's not for those with HIV, cystic fibrosis, certain NTM diseases, active tuberculosis or fungal infections, high-dose steroid users, organ transplant recipients, or anyone unable to consent.

Inclusion Criteria

Ability to provide informed consent
You have symptoms that match the guidelines for diagnosing lung diseases set by the American Thoracic Society and Infectious Disease Society of America in 2007.
I have had at least 2 positive lung infection tests in the last year.
See 2 more

Exclusion Criteria

I have been taking more than 15 mg/day of corticosteroids for over 3 months.
I have been diagnosed with HIV.
I have been diagnosed with Cystic Fibrosis.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either hypertonic saline or standard of care for 12 weeks. The treatment group takes inhaled hypertonic saline twice daily.

12 weeks
Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including final visit, sputum collection, and AE assessment.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Azithromycin
  • Ethambutol
  • Hypertonic Saline
  • Rifampin
Trial Overview The study examines if inhaling hypertonic saline can help reduce symptoms and improve mycobacteria clearance in patients with M. avium complex lung disease. Participants will also receive standard treatments like Azithromycin, Ethambutol, and Rifampin.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Hypertonic salineExperimental Treatment1 Intervention
Group II: Standard of CareActive Control3 Interventions

Azithromycin is already approved in European Union, United States, Canada for the following indications:

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Approved in European Union as Azithromycin for:
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Approved in United States as Azithromycin for:
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Approved in Canada as Azithromycin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials
1,024
Recruited
7,420,000+

New York University

Collaborator

Trials
249
Recruited
229,000+

NTM Info & Research, Inc.

Collaborator

Trials
1
Recruited
50+

University Health Network, Toronto

Collaborator

Trials
1,555
Recruited
526,000+

Published Research Related to This Trial

In a study involving congenitally athymic (nude) mice, the antibiotics rifapentine, azithromycin, and ethambutol were found to be highly effective against Mycobacterium kansasii when administered individually.
However, when these drugs were used in combination, they did not show increased effectiveness compared to their individual use, indicating that combining these therapies may not provide additional benefits.
Treatment alternatives for Mycobacterium kansasii.Graybill, JR., Bocanegra, R.[2019]
In two cases of Mycobacterium avium-intracellulare complex (MAC) infections, one child with AIDS died despite treatment, highlighting the challenges in managing MAC in immunocompromised patients.
The second child, without immunodeficiency, successfully recovered from a MAC-related mass after a combination therapy including streptomycin, ethambutol, clofazimine, and rifabutin, demonstrating that aggressive multidrug therapy can be effective in non-immunocompromised individuals.
Treatment of nontuberculous mycobacterial infections in pediatric patients.Levin, RH., Bolinger, AM.[2013]
In a study of 119 patients with Mycobacterium avium complex lung disease, the two-drug regimen of clarithromycin and ethambutol resulted in a higher rate of sputum culture conversion (55.0%) compared to the three-drug regimen that included rifampicin (40.6%).
The incidence of adverse events leading to treatment discontinuation was higher in the three-drug group (37.2%) compared to the two-drug group (26.6%), suggesting that the simpler regimen may be safer and equally effective.
Efficacy of clarithromycin and ethambutol for Mycobacterium avium complex pulmonary disease. A preliminary study.Miwa, S., Shirai, M., Toyoshima, M., et al.[2014]

Citations

Treatment alternatives for Mycobacterium kansasii. [2019]
Treatment of nontuberculous mycobacterial infections in pediatric patients. [2013]
Efficacy of clarithromycin and ethambutol for Mycobacterium avium complex pulmonary disease. A preliminary study. [2014]
Activities of rifabutin, clarithromycin, and ethambutol against two virulent strains of Mycobacterium avium in a mouse model. [2021]
The individual microbiologic effect of three antimycobacterial agents, clofazimine, ethambutol, and rifampin, on Mycobacterium avium complex bacteremia in patients with AIDS. [2019]
Comparison of azithromycin and clarithromycin in their interactions with rifabutin in healthy volunteers. [2013]
Adverse events associated with high-dose rifabutin in macrolide-containing regimens for the treatment of Mycobacterium avium complex lung disease. [2019]
Comparative activity of azithromycin against clinical isolates of mycobacteria. [2019]
Nontuberculous mycobacterial pulmonary disease in a patient with unilateral pulmonary artery agenesis: Case report. [2023]
Efficacy and outcomes of clarithromycin treatment for pulmonary MAC disease. [2013]
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