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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment that combines nebulized hypertonic saline (a salty mist) with chest percussion therapy (gentle tapping on the chest) to aid young children with acute bronchiolitis, a common lung infection. The goal is to determine the effectiveness of this combination in improving breathing in hospitalized children under 2 years old who require extra oxygen. Eligible children have been diagnosed with acute bronchiolitis and are receiving supplemental oxygen in a regular pediatric ward, not intensive care. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment benefits more patients.

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 is the safety track record for the combined nebulized hypertonic saline and chest percussion therapy?

Research has shown that nebulized hypertonic saline is generally safe for infants with bronchiolitis. Studies have specifically examined its safety for this age group. Some mild side effects, such as a worsening cough, have been observed. These side effects are not serious and are more of an inconvenience than a risk. As this trial is in a later phase, more information about its safety is available. Researchers have administered the treatment to many patients and have carefully monitored for any problems. Overall, this suggests the treatment is well-tolerated. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the combined nebulized hypertonic saline and chest percussion therapy for bronchiolitis because it offers a unique approach to clearing airway congestion. Unlike standard treatments, which often focus on supportive care like oxygen therapy and hydration, this combination directly targets mucus build-up. Hypertonic saline helps to draw moisture into the airways, thinning the mucus, while chest percussion aids in physically dislodging it, potentially speeding up recovery and improving breathing. This dual-action method could offer quicker relief for young patients compared to traditional care methods.

What evidence suggests that combined nebulized hypertonic saline and chest percussion therapy is effective for bronchiolitis?

Research shows that hypertonic saline, a saltwater solution, can help thin mucus, making it easier to clear from the lungs. In the case of bronchiolitis, studies have shown mixed results. Some research found that nebulized hypertonic saline might not significantly lower hospital admissions for infants with acute bronchiolitis. However, this trial will provide participants with a combination of nebulized hypertonic saline and chest percussion therapy, which involves gently tapping on the chest to help move mucus. This combination aims to improve breathing by clearing the airways more effectively. ^{1 2 3 4 6}

Who Is on the Research Team?

Tuan Nguyen

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06441162

Efficacy Of Combined Nebulized Hypertonic Saline and ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6583778/

Effect of Nebulized Hypertonic Saline Treatment in Emergency ... Nebulized hypertonic saline treatment did not significantly reduce the hospital admission rate among infants with a first episode of acute ...

3. withpower.com withpower.com/trial/phase-4-bronchiolitis-5-2024-c6db1

Hypertonic Saline + Chest Percussion for Bronchiolitis 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 ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06441162/efficacy-of-combined-nebulized-hypertonic-saline-and-chest-percussion-therapy-in-acute-viral-bronchiolitis

Efficacy Of Combined Nebulized Hypertonic Saline and ... This study will examine the efficacy of combined nebulized hypertonic saline with chest percussion therapy in patients age 0 to 24 months ...

5. clinconnect.io clinconnect.io/trials/NCT06441162

Efficacy Of Combined Nebulized Hypertonic Saline and 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 ...

6. journalslibrary.nihr.ac.uk journalslibrary.nihr.ac.uk/hta/HTA19660

Saline in Acute Bronchiolitis RCT and Economic evaluation The study found that the use of hypertonic saline in infants with acute bronchiolitis had no clinical benefit on the length of hospital stay ...