Hypertonic Saline for Bronchiectasis

Overseen by Katherine A. Despotes, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Inhaled acetylcysteine, Dornase alfa

Disqualifiers: Cystic fibrosis, Severe asthma, Pregnancy, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this single arm clinical trial is to evaluate the effects of 7% hypertonic saline (HS) delivered by nebulizer on clearance of mucus from the lungs in people with bronchiectasis (dilated airways) not due to cystic fibrosis. Mucociliary clearance (MCC) to measure the rate at which a person's lungs can clear inhaled particles will be assessed at baseline, and after acute (single dose) HS treatment, as well as after two weeks of treatment with HS. The study has two main questions: 1. Evaluate the repeatability MCC measures in people with non-CF bronchiectasis 2. Compare MCC at baseline (before treatment with HS), after a single dose of HS (acute effect of HS), and after two weeks of treatment with HS twice a day (sustained effect of HS). Participants will participate in up to 5 study visits if completing both Aim 1 and Aim 2: 1 screening/enrollment visit, 2 baseline visits (1 baseline visit if only participating in Aim 2), 1 visit during which first dose of HS would be administered and assessed, and 1 visit after 2 weeks of treatment with HS.

Do I need to stop my current medications for the trial?

The trial requires participants to stop using inhaled acetylcysteine or dornase alfa. Additionally, there is a 2-week washout period (time without taking certain medications) for hypertonic saline before the first baseline scan.

What data supports the effectiveness of the treatment Hypertonic Saline for Bronchiectasis?

Research shows that inhaling hypertonic saline can improve lung function and quality of life in people with bronchiectasis by helping clear mucus from the airways. Studies have found that both 3% and 7% hypertonic saline solutions are effective in managing symptoms and improving respiratory health in patients with this condition. ^{1 2 3 4 5}

Is hypertonic saline safe for humans?

Research shows that hypertonic saline is generally safe for people with bronchiectasis, although some may experience mild side effects like cough, throat irritation, or a salty taste. ^{1 2 3 4 6}

How is hypertonic saline different from other treatments for bronchiectasis?

Hypertonic saline is unique because it helps clear mucus from the lungs by drawing water into the airways, making it easier to cough up the mucus. This treatment is administered through a nebulizer (a device that turns liquid medicine into a mist) and has been shown to improve lung function and quality of life in patients with bronchiectasis. ^{1 2 3 5 7}

Research Team

Katherine A. Despotes, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for individuals with non-cystic fibrosis bronchiectasis, which means they have widened airways that make it hard to clear mucus. Participants will need to attend five study visits and undergo tests to see how well their lungs can get rid of inhaled particles.

Inclusion Criteria

I needed antibiotics for a lung condition flare-up once last year.

I am over 18 and can give my consent.

My CT scan shows bronchiectasis in at least 2 lobes, including the right lung.

Exclusion Criteria

Smoking/vaping, any substance within the past year, or >10 pack-years of cigarette use over their lifetime

I am being treated for a non-tuberculous mycobacterial infection.

I have severe asthma and need strong medication, have been hospitalized for it, or have bronchiectasis due to asthma.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Baseline

Baseline MCC scans and other assessments are performed to assess variability

2 weeks

2 visits (in-person)

Acute Treatment

Acute response to HS on MCC is assessed after the first dose of HS is administered

1 day

1 visit (in-person)

Treatment

Participants receive 7% HS by nebulizer twice a day for two weeks

2 weeks

Home treatment

Follow-up

Participants are monitored for sustained response to HS and complete post-treatment assessments

1 visit

1 visit (in-person)

Treatment Details

Interventions

• Hypertonic Saline (Other)

Trial Overview The trial is testing the effects of inhaling a saltwater solution called 7% hypertonic saline through a nebulizer. It aims to see if this treatment helps clear mucus from the lungs more effectively after one dose and after two weeks of use.

Participant Groups

Group I: Single arm treatment group with 7% HS Experimental Treatment 1 Intervention

All study participants will receive 7% HS by nebulizer twice a day for two weeks as part of airway clearance.

Hypertonic Saline is already approved in Canada for the following indications:

Approved in Canada as 3% Sodium Chloride Solution for:

• Severe hyponatremia
• Cerebral edema
• Increased intracranial pressure

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

Cystic Fibrosis Foundation

Collaborator

Trials

199

Recruited

37,800+

Michael P. Boyle

Cystic Fibrosis Foundation

Chief Executive Officer since 2019

MD from Johns Hopkins University

Albert Faro

Cystic Fibrosis Foundation

Chief Medical Officer since 2023

MD

Findings from Research

In a clinical analysis of adults with bronchiectasis, nebulizer therapy using hypertonic NaCl solution combined with hyaluronic acid showed immediate positive effects, including a significant decrease in shortness of breath by 17.6% and improvements in respiratory function after just two weeks.

The treatment led to increased FEV1 by 8.6% and improved blood oxygen saturation levels, indicating that this therapy can enhance respiratory health and physical tolerance in patients with bronchiectasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BRONCHIECTASIS IN ADULT PATIENTS: CLINICAL PECULIARITIES AND APPROACHES TO THE TREATMENT. Rudnyk, V., Chaplynska, N., Skrypnyk, L.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

The efficacy of inhaled hypertonic saline for bronchiectasis: a meta-analysis of randomized controlled studies. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Nebulised 7% hypertonic saline improves lung function and quality of life in bronchiectasis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of hypertonic saline nebulization in airway clearance in children with non-cystic fibrosis bronchiectasis: A randomized control trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The long term effect of inhaled hypertonic saline 6% in non-cystic fibrosis bronchiectasis. [2022]

5. Poland pubmed.ncbi.nlm.nih.gov

BRONCHIECTASIS IN ADULT PATIENTS: CLINICAL PECULIARITIES AND APPROACHES TO THE TREATMENT. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Nebulized hypertonic saline in noncystic fibrosis bronchiectasis: a comprehensive review. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Impact of Hypertonic Saline Solutions on Sputum Expectoration and Their Safety Profile in Patients with Bronchiectasis: A Randomized Crossover Trial. [2019]