What side effects are associated with this type of intervention?

Common treatments for Nontuberculous Mycobacterial Lung Disease include the use of hypertonic saline, which helps thin mucus and aid in its clearance. Known side effects of hypertonic saline inhalation include coughing, throat irritation, and a potential decrease in lung function (FEV1), although these changes are generally not clinically significant. Other treatments, such as antibiotics (e.g., macrolides, rifamycins, and ethambutol), can cause side effects like gastrointestinal upset, liver toxicity, and, in some cases, hearing loss or vision changes. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of Nontuberculous Mycobacterial (NTM) Lung Disease include antibiotics such as clarithromycin, ethambutol, rifabutin, and amikacin. These drugs target the bacteria directly to manage the infection. Additionally, hypertonic saline is being studied for its supportive role in improving symptoms and aiding in the clearance of mycobacteria by drawing water out of lung tissues to thin mucus.

What other types of research exist?

Promising alternatives to hypertonic saline for Nontuberculous Mycobacterial Lung Disease include inhaled mannitol, which has been shown to improve mucociliary clearance, and airway clearance therapies such as positive expiratory pressure (PEP) physiotherapy and high-frequency chest wall oscillation (HFCWO). These alternatives have demonstrated efficacy in mucus clearance and may offer better tolerability for some patients.

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Antibiotic

Hypertonic Saline for Nontuberculous Mycobacterial Lung Disease

Phase 4

Recruiting

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 and older

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

Must not have

Current use of chronic systemic corticosteroids at doses of 15 mg/day for more than 3 months

Diagnosis of HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include irritation of the airways from hypertonic saline inhalation leading to coughing or wheezing; gastrointestinal issues from Azithromycin; vision problems or stomach pain from Ethambutol; and liver issues or flu-like symptoms from Rifampin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have had at least 2 positive lung infection tests in the last year.

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I have been diagnosed with Bronchiectasis or it has been seen on my chest CT.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been taking more than 15 mg/day of corticosteroids for over 3 months.

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I have been diagnosed with HIV.

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I have been diagnosed with Cystic Fibrosis.

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My condition involves lung cavities due to NTM infection.

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I am currently being treated for active tuberculosis or a serious fungal infection.

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I have had a lung or other solid organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Culture conversion

Secondary study objectives

Semi-quantitative culture results

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypertonic saline

2017

Completed Phase 4

~1320

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Nontuberculous Mycobacterial (NTM) Lung Disease include antibiotics such as macrolides, rifamycins, and ethambutol, which work by inhibiting bacterial protein synthesis, RNA synthesis, and cell wall synthesis, respectively. Hypertonic saline, a treatment under study, draws water out of lung tissues to thin mucus, aiding in the clearance of mycobacteria. This is crucial for NTM patients as it helps reduce bacterial load and improve lung function by enhancing mucociliary clearance, thereby alleviating symptoms and potentially improving clinical outcomes.

[Study of the mucociliary transport rate in evaluating the effectiveness of the treatment of suppurative endobronchitis by CO2 laser].Nebulised hypertonic saline for cystic fibrosis.The long and winding road to inhaled TB therapy: not only the bug's fault.