Hypertonic Saline + Chest Percussion for Bronchiolitis

Overseen By Tuan Nguyen

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: NYU Langone Health

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

Disqualifiers: Asthma, Pneumonia, Pulmonary edema, 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: Unknown

Duration: 1-5 days

114 Participants Needed

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. ^{1 2 3 4 5}

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. ^{5 6 7 8 9}

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. ^{1 2 3 4 10}

Research Team

Tuan Nguyen

Principal Investigator

NYU Langone Health

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.

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

Treatment Details

Interventions

• Combined Nebulized Hypertonic Saline and Chest Percussion Therapy

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

Nebulized epinephrine combined with high-dose dexamethasone or nebulized hypertonic saline shows potential as effective treatments for viral bronchiolitis in young infants.

Despite these promising strategies, more research is necessary to establish clear guidelines and recommendations for their use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pediatrics. New treatment options for viral bronchiolitis]. Rochat, I., Hafen, G.[2013]

In a study involving 101 infants with moderate to severe acute bronchiolitis, the use of 7% hypertonic saline (HS) with epinephrine did not result in a significant improvement in bronchiolitis severity scores compared to 0.9% saline with epinephrine.

There were no significant differences in hospitalization rates, length of stay in the emergency department or inpatient settings, or the proportion of admitted patients discharged within 23 hours between the two treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

7% Hypertonic saline in acute bronchiolitis: a randomized controlled trial. Jacobs, JD., Foster, M., Wan, J., et al.[2014]

In a review of five double-blind placebo-controlled studies involving hospitalized infants with acute viral bronchiolitis, nebulizations of 3% hypertonic saline (HS) led to a 20% improvement in clinical severity scores and reduced hospital stays by 24 hours.

Hypertonic saline was well-tolerated in infants, suggesting it is a safe treatment option, although further research is needed to determine optimal salt concentrations, nebulizer types, and usage frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nebulized hypertonic saline and acute viral bronchiolitis in infants: current aspects]. Sauvaget, E., David, M., Bresson, V., et al.[2012]

In a study involving 96 hospitalized infants with viral bronchiolitis, nebulized 3% hypertonic saline (HS) significantly reduced the length of hospital stay by 26%, averaging 2.6 days compared to 3.5 days for those receiving normal saline.

The treatment was found to be safe and well tolerated, with no adverse effects linked to the use of hypertonic saline, making it an effective and inexpensive option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nebulized hypertonic saline in the treatment of viral bronchiolitis in infants. Kuzik, BA., Al-Qadhi, SA., Kent, S., et al.[2013]

Nebulized 3% hypertonic saline (HS) significantly reduced clinical severity scores in infants with mild to moderately severe bronchiolitis compared to 0.9% normal saline, indicating its efficacy in treatment.

The treatment was well tolerated with no adverse effects, and more infants in the HS group were able to be discharged from outpatient care within 2 hours and had fewer hospital re-visits within 24 hours, demonstrating its safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nebulised hypertonic saline (3%) among children with mild to moderately severe bronchiolitis--a double blind randomized controlled trial. Khanal, A., Sharma, A., Basnet, S., et al.[2018]

Inhaled nebulized 5% hypertonic saline (HS) significantly improved clinical symptoms in infants with acute bronchiolitis compared to 3% HS and 0.9% normal saline, with a notable reduction in clinical severity scores after 72 hours.

While 5% HS was more effective, it was associated with a higher incidence of paroxysmal cough (3.75% of patients), indicating a potential safety concern that should be monitored during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of inhaled hypertonic saline in children with bronchiolitis]. Li, G., Zhao, J.[2016]

In a study of 93 infants with mild to moderate bronchiolitis, treatment with nebulized 3% hypertonic saline solution combined with salbutamol significantly reduced wheezing and cough remission times compared to normal saline, with wheezing remission at 2.7 days versus 3.8 days in the control group.

The treatment also led to a shorter average hospital stay, decreasing from 7.4 days in the control group to 6.0 days in the treatment group, and no significant adverse effects were reported, indicating both safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nebulized hypertonic saline/salbutamol solution treatment in hospitalized children with mild to moderate bronchiolitis. Luo, Z., Liu, E., Luo, J., et al.[2016]

In a review of 24 trials with 3209 infants, nebulized hypertonic saline (HS) significantly reduced the length of hospital stays by an average of 0.45 days compared to standard saline treatments.

Nebulized HS also lowered the risk of hospitalization by 20% for outpatients and showed no significant adverse effects, indicating it is a safe and effective option for treating acute bronchiolitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nebulized Hypertonic Saline for Acute Bronchiolitis: A Systematic Review. Zhang, L., Mendoza-Sassi, RA., Klassen, TP., et al.[2018]

In a study of 444 doses of nebulized 3% saline solution given to infants with bronchiolitis, the adverse event rate was low at 1.0%, indicating that this treatment is generally safe when used without bronchodilators.

Among the adverse events, only one case of bronchospasm was reported, resulting in a very low rate of 0.3%, suggesting that nebulized saline can be a safe option for managing bronchiolitis in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Ralston, S., Hill, V., Martinez, M.[2010]

Nebulised hypertonic saline (≥ 3%) may reduce the length of hospital stay for infants with acute bronchiolitis, showing a mean difference of -0.40 days compared to normal saline, based on a review of 34 trials involving 5205 infants.

The treatment appears to be safe, with most adverse events being mild and resolving on their own, particularly when hypertonic saline is used alongside bronchodilators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nebulised hypertonic saline solution for acute bronchiolitis in infants. Zhang, L., Mendoza-Sassi, RA., Wainwright, CE., et al.[2023]

References

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

[Pediatrics. New treatment options for viral bronchiolitis]. [2013]

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

7% Hypertonic saline in acute bronchiolitis: a randomized controlled trial. [2014]

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

[Nebulized hypertonic saline and acute viral bronchiolitis in infants: current aspects]. [2012]

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

Nebulized hypertonic saline in the treatment of viral bronchiolitis in infants. [2013]

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]

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

[Effectiveness of inhaled hypertonic saline in children with bronchiolitis]. [2016]

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

Nebulized hypertonic saline/salbutamol solution treatment in hospitalized children with mild to moderate bronchiolitis. [2016]

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

Nebulized Hypertonic Saline for Acute Bronchiolitis: A Systematic Review. [2018]

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

Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. [2010]

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

Nebulised hypertonic saline solution for acute bronchiolitis in infants. [2023]