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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of a salty solution, known as hypertonic saline, on individuals with bronchiectasis, a condition where the airways in the lungs widen, leading to mucus buildup. The study aims to assess how well the lungs can clear mucus after using this treatment both once and over a two-week period. It suits adults diagnosed with bronchiectasis (not related to cystic fibrosis), who have a chronic cough and have experienced past flare-ups requiring antibiotics. Participants will inhale the treatment using a nebulizer twice a day. As a Phase 4 trial, this research focuses on understanding how this already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for this treatment?

Research has shown that using a nebulizer with 7% hypertonic saline (HS) is generally safe for people with bronchiectasis. Most patients manage the treatment well, though some may experience mild side effects such as coughing, throat irritation, or a salty taste. Importantly, regular use of 7% HS improves lung function and quality of life in patients with non-cystic fibrosis bronchiectasis. While the treatment is effective, discussing any concerns or side effects with a doctor is advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Hypertonic saline is unique because it uses a high concentration of salt solution, specifically 7%, delivered via a nebulizer to help clear the airways in people with bronchiectasis. This approach stands out because it enhances the natural process of mucus clearance by drawing water into the airways, making it easier to expel mucus. Researchers are excited about this treatment because it could offer a more effective, non-invasive way to improve lung function and reduce symptoms faster than some conventional treatments, like oral antibiotics or chest physiotherapy, which can take longer to show results.

What evidence suggests that hypertonic saline might be an effective treatment for bronchiectasis?

Research has shown that 7% hypertonic saline (HS) can help individuals with bronchiectasis, not caused by cystic fibrosis, breathe more easily and improve their quality of life. In this trial, participants will use 7% HS by nebulizer twice daily for two weeks as part of airway clearance. Studies indicate that regular use of this treatment helps clear mucus from the lungs, facilitating easier breathing. One study found that patients using 7% HS experienced better lung health and required fewer healthcare visits. While some may experience a cough or a salty taste, many tolerate the treatment well. Overall, evidence suggests that 7% HS effectively aids breathing and enhances quality of life for those with bronchiectasis. ^{1 2 3 4 6}

Who Is on the Research Team?

Katherine A. Despotes, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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.

My lung function improved significantly after using a bronchodilator.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6639771/

Efficacy of 3% hypertonic saline in bronchiolitis: A meta-analysis Our analysis, based on 23 studies, demonstrated that 3% HS was more effective compared with 0.9% NS in decreasing the length of hospitalization, CSS score and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S095461111100254X

Nebulised 7% hypertonic saline improves lung function ... Regular use of 7% hypertonic saline improves lung function, quality of life and health care utilisation in non-cystic fibrosis bronchiectasis patients.

3. publications.ersnet.org publications.ersnet.org/content/erj/44/4/913

The effect of 3% and 6% hypertonic saline in viral bronchiolitis Nebulised hypertonic saline (HS), using sodium chloride, may have positive effects on bronchiolitis, as it may reduce submucosal swelling, decrease ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6688147/

Nebulized hypertonic saline in noncystic fibrosis bronchiectasis A high percentage of patients with CF and bronchiectasis tolerate HS solutions, but often patients report cough, dyspnoea, throat irritation, or salty taste ...

5. liebertpub.com liebertpub.com/doi/10.1089/jamp.2017.1443

Impact of Hypertonic Saline Solutions on Sputum ... This study evaluated whether HA+HS solution enhances similar sputum quantity with better safety profile than HS alone in patients with bronchiectasis.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22018993/

Nebulised 7% hypertonic saline improves lung function ... Regular use of 7% hypertonic saline improves lung function, quality of life and health care utilisation in non-cystic fibrosis bronchiectasis patients.