~2 spots leftby Jun 2025

Hypertonic Saline for Nontuberculous Mycobacterial Lung Disease

Recruiting at2 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Oregon Health and Science University
Must not be taking: Bedaquiline, Macrolide, Ethambutol, Rifampin
Disqualifiers: HIV, Cystic fibrosis, Tuberculosis, others
No Placebo Group
Prior Safety Data

Trial Summary

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.

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.12345

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.14567

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.148910

Research Team

Eligibility Criteria

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 am 18 years old or older.
See 3 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

Trial Timeline

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

Treatment Details

Interventions

  • Azithromycin (Antibiotic)
  • Ethambutol (Antibiotic)
  • Hypertonic Saline (Other)
  • Rifampin (Antibiotic)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Hypertonic salineExperimental Treatment1 Intervention
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.
Group II: Standard of CareActive Control3 Interventions
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.

Azithromycin is already approved in Canada for the following indications:

🇨🇦
Approved in Canada as Azithromycin for:
  • Respiratory tract infections
  • Skin and soft tissue infections
  • Sexually transmitted diseases
  • Toxoplasmosis
  • Malaria
  • Preterm prelabor rupture of membranes

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+
John Hunter profile image

John Hunter

Oregon Health and Science University

Chief Medical Officer since 2024

MD, specific details unavailable

Ann Madden Rice profile image

Ann Madden Rice

Oregon Health and Science University

Chief Executive Officer

FACHE certification, extensive leadership experience in academic health centers

New York University

Collaborator

Trials
249
Recruited
229,000+
Dr. Fritz François profile image

Dr. Fritz François

New York University

Chief Medical Officer

MD from NYU Grossman School of Medicine

Dr. Robert I. Grossman profile image

Dr. Robert I. Grossman

New York University

Chief Executive Officer since 2007

MD from NYU Grossman School of Medicine

NTM Info & Research, Inc.

Collaborator

Trials
1
Recruited
50+

University Health Network, Toronto

Collaborator

Trials
1,555
Recruited
526,000+
Dr. Brad Wouters profile image

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith profile image

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto

Findings from Research

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]

References

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]