Hypertonic Saline + Chest Percussion for Bronchiolitis

Recruiting in Palo Alto (17 mi)

Overseen by Tuan Nguyen

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: NYU Langone Health

Must not be taking: Bronchodilators, Antibiotics, Antivirals, others

Disqualifiers: Asthma, Pneumonia, Pulmonary edema, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will examine the efficacy of combined nebulized hypertonic saline with chest percussion therapy in patients age 0 to 24 months admitted to the general inpatient pediatrics unit with acute bronchiolitis. 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy will be administered every 6 hours of patients selected for the study.

Will I have to stop taking my current medications?

Yes, participants must stop taking certain medications. If you are receiving respiratory treatments like bronchodilators or adjuvant therapies such as antibiotics, antivirals, glucocorticoids, corticosteroids, or diuretics, you cannot participate in the study.

What data supports the effectiveness of the treatment Combined Nebulized Hypertonic Saline and Chest Percussion Therapy for bronchiolitis?

Research shows that nebulized hypertonic saline (a saltwater solution) can improve symptoms in infants with bronchiolitis by helping clear mucus from the airways. Studies found that using a 3% hypertonic saline solution improved clinical severity scores by 20% and reduced hospital stays by about a day.

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Is hypertonic saline safe for humans?

Research shows that nebulized hypertonic saline is generally safe for infants with bronchiolitis, with studies specifically assessing its safety in this group.

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How is the treatment of hypertonic saline and chest percussion for bronchiolitis different from other treatments?

This treatment is unique because it combines nebulized hypertonic saline, which helps clear mucus by drawing water into the airways, with chest percussion therapy, which physically helps loosen mucus, potentially offering a more comprehensive approach to managing bronchiolitis symptoms compared to using hypertonic saline alone.

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Eligibility Criteria

This trial is for young patients, from newborns up to 2 years old, who are hospitalized with acute bronchiolitis. The study will include those who meet the specific age requirement and have been diagnosed with this respiratory condition.

Inclusion Criteria

Individual must be admitted to the general inpatient pediatrics unit

I have been diagnosed with acute bronchiolitis.

I am currently using supplemental oxygen.

Exclusion Criteria

I have other lung conditions like pneumonia or asthma.

Individual has an absolute contraindication to nebulized 3% hypertonic saline, for example, a history of an allergic or anaphylactic reaction

I have a chronic lung condition.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy every 6 hours

1-5 days

Continuous inpatient care

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Participant Groups

The study tests if breathing in a saltwater mist (nebulized hypertonic saline) combined with tapping on the chest using special cups (chest percussion therapy) every six hours helps treat infants and toddlers hospitalized with acute bronchiolitis.

Group I: Nebulized Hypertonic Saline + Chest Percussion Therapy Experimental Treatment 2 Interventions

Participants with acute viral bronchiolitis will receive 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy. This will be administered every 6 hours.

Group II: Control Arm Active Control 1 Intervention

Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial.

Combined Nebulized Hypertonic Saline and Chest Percussion Therapy is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Nebusal 7% for:

• Bronchiectasis
• Cystic Fibrosis
• Acute Viral Bronchiolitis

🇺🇸 Approved in United States as MucoClear for:

• Cystic Fibrosis
• Acute Viral Bronchiolitis

🇨🇦 Approved in Canada as Hypertonic Saline Solution for:

• Bronchiectasis
• Cystic Fibrosis
• Acute Viral Bronchiolitis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NYU Langone Health Mineola, NY

Who Is Running the Clinical Trial?

NYU Langone Health Lead Sponsor

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Pediatrics. New treatment options for viral bronchiolitis]. [2013] The combination of nebulized epinephrine and high dose dexamethasone, or nebulized hypertonic saline, are promising new therapeutic strategies for viral bronchiolitis in the young infant. However, further research is needed before a general recommendation can be given.

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

7% Hypertonic saline in acute bronchiolitis: a randomized controlled trial. [2014] Research suggests that hypertonic saline (HS) may improve mucous flow in infants with acute bronchiolitis. Data suggest a trend favoring reduced length of hospital stay and improved pulmonary scores with increasing concentration of nebulized solution to 3% and 5% saline as compared with 0.9% saline mixed with epinephrine. To our knowledge, 7% HS has not been previously investigated.

3. France pubmed.ncbi.nlm.nih.gov

[Nebulized hypertonic saline and acute viral bronchiolitis in infants: current aspects]. [2012] Acute viral bronchiolitis affects infants, is frequent, and can be severe. Its treatment is only based on symptoms. Hypertonic saline (HS) may act favorably in this situation by fighting virus-induced dehydration of the airway liquid surface. Because of an osmotic action, HS attracts the water from the epithelial cells and improves mucociliary clearance. Five double-blind placebo-controlled studies concerning hospitalized infants with acute viral bronchiolitis showed that repeated nebulizations of 3% HS induce a 20% improvement in the clinical severity score and reduced the hospital length of stay by 24h. Tolerance is excellent. On the other hand, a few questions remain unresolved: what is the optimal salt concentration? What is the recommended nebulizer? What is the best frequency for nebulizer use? Can nebulized HS be used at home? What are the results with systematic physiotherapy when HS is used?

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

Nebulized hypertonic saline in the treatment of viral bronchiolitis in infants. [2013] To investigate the use of nebulized 3% hypertonic saline (HS) for treating viral bronchiolitis in moderately ill hospitalized infants by a prospective, randomized, double-blinded, controlled, multicenter trial.

5. England pubmed.ncbi.nlm.nih.gov

Nebulised hypertonic saline (3%) among children with mild to moderately severe bronchiolitis--a double blind randomized controlled trial. [2018] To Assess the efficacy of nebulised hypertonic saline (HS) (3%) among children with mild to moderately severe bronchiolitis.

6. China pubmed.ncbi.nlm.nih.gov

[Effectiveness of inhaled hypertonic saline in children with bronchiolitis]. [2016] To assess the efficacy and safety of inhaled nebulized hypertonic saline (HS) solution in infants with acute bronchiolitis.

7. Australia pubmed.ncbi.nlm.nih.gov

Nebulized hypertonic saline/salbutamol solution treatment in hospitalized children with mild to moderate bronchiolitis. [2016] The objective of this study was to determine the efficacy and safety of nebulized 3% hypertonic saline solution and salbutamol in the treatment of mild to moderate bronchiolitis.

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

Nebulized Hypertonic Saline for Acute Bronchiolitis: A Systematic Review. [2018] The mainstay of treatment for acute bronchiolitis remains supportive care. The objective of this study was to assess the efficacy and safety of nebulized hypertonic saline (HS) in infants with acute bronchiolitis.

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

Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. [2010] The goal was to determine an adverse event rate for nebulized hypertonic saline solution administered without adjunctive bronchodilators for infants with bronchiolitis.

10. England pubmed.ncbi.nlm.nih.gov

Nebulised hypertonic saline solution for acute bronchiolitis in infants. [2023] Airway oedema (swelling) and mucus plugging are the principal pathological features in infants with acute viral bronchiolitis. Nebulised hypertonic saline solution (≥ 3%) may reduce these pathological changes and decrease airway obstruction. This is an update of a review first published in 2008, and updated in 2010, 2013, and 2017.