Hypertonic Saline for Bronchiectasis

Overseen By Alex Nesbit

Age: 18+

Sex: Any

Trial Phase: Phase 4

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 All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

20 Participants Needed

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.

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

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 United States, European Union, Canada for the following indications:

Approved in United States as Hypertonic Saline for:

• Severe hyponatremia
• Cerebral edema
• Increased intracranial pressure

Approved in European Union as Hypertonic Sodium Chloride Solution for:

• Severe hyponatremia
• Cerebral edema
• Increased intracranial pressure

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+

Cystic Fibrosis Foundation

Collaborator

Trials

199

Recruited

37,800+

Findings from Research

A systematic review and meta-analysis of four randomized controlled trials found that inhaled hypertonic saline does not significantly improve lung function or symptoms in patients with bronchiectasis compared to 0.9% isotonic saline.

Both treatments showed similar efficacy, indicating that inhaled hypertonic saline may not provide additional benefits over isotonic saline for managing bronchiectasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of inhaled hypertonic saline for bronchiectasis: a meta-analysis of randomized controlled studies. Xie, B., Liu, P., Wu, Q., et al.[2021]

In a study involving 32 patients with non-cystic fibrosis bronchiectasis, the use of 7% hypertonic saline significantly improved lung function compared to 0.9% sodium chloride, with notable increases in FEV1 and FVC (p<0.01).

Patients using 7% hypertonic saline also reported better quality of life and reduced healthcare utilization, including fewer antibiotic courses and emergency visits, highlighting its efficacy in managing symptoms and complications of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nebulised 7% hypertonic saline improves lung function and quality of life in bronchiectasis. Kellett, F., Robert, NM.[2022]

In a study involving 52 children with non-cystic fibrosis bronchiectasis, the use of 3% hypertonic saline (HS) before airway clearance techniques significantly improved lung function, as shown by greater increases in forced expiratory volume and forced vital capacity compared to conventional methods.

Children receiving HS experienced fewer exacerbations during the first phase of the study, indicating a potential reduction in disease-related complications, although this effect was less pronounced in the second phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of hypertonic saline nebulization in airway clearance in children with non-cystic fibrosis bronchiectasis: A randomized control trial. Anuradha, KWDA., Gunathilaka, PKG., Wickramasinghe, VP.[2021]

Inhalation of hypertonic saline (HTS) 6% did not show a significant advantage over isotonic saline (IS) 0.9% in reducing exacerbation rates or improving quality of life in patients with non-cystic fibrosis bronchiectasis over a 12-month period, based on a study involving 40 patients.

Both HTS and IS led to similar improvements in respiratory function, with significant increases in FEV1 and FEF(25-75%), and a reduction in sputum colonization, indicating that both treatments are effective options for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The long term effect of inhaled hypertonic saline 6% in non-cystic fibrosis bronchiectasis. Nicolson, CH., Stirling, RG., Borg, BM., et al.[2022]

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]

Hypertonic saline (HS) solutions are recommended to help improve mucociliary clearance in patients with bronchiectasis, but evidence supporting their effectiveness in this condition is limited.

While many patients tolerate HS solutions, common side effects like cough and throat irritation can lead to treatment discontinuation; however, adding hyaluronic acid may enhance tolerability and improve adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nebulized hypertonic saline in noncystic fibrosis bronchiectasis: a comprehensive review. Máiz Carro, L., Martínez-García, MA.[2020]

In a study involving 28 patients with bronchiectasis, both hyaluronic acid plus hypertonic saline (HA+HS) and hypertonic saline (HS) were found to be more effective than isotonic saline (IS) in promoting sputum expectoration, with HA+HS showing a better safety profile.

The study indicated that while HA+HS and HS had similar effects on sputum production, HS was associated with more severe adverse events, suggesting that HA+HS may be a safer alternative for mucoactive treatment in bronchiectasis.

NCBI (Pubmed)

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. Herrero-Cortina, B., Alcaraz, V., Vilaró, J., et al.[2019]

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]