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Bronchodilator Response in Children with Bronchiolitis

This study is looking at how children with bronchiolitis (a common lung infection in babies and young children) respond to treatments. Researchers want to understand if albuterol sulfate, a medicine often used for breathing problems, helps children with bronchiolitis, or if a salt water solution (sodium chloride) works just as well. You or your child might be eligible if your child is between 3 and 24 months old and has been diagnosed with bronchiolitis. The study will look at how much your child's breathing improves right after treatment and also examine genetic factors that might affect how well the treatment works. The current status of this study is unclear, and it plans to enroll 400 children.

Study design
This is an interventional study that will randomize 400 participants to receive either albuterol sulfate or sodium chloride. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure immediate improvement after intervention and genetic variants through study completion, which averages 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06946264

Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features

Recruiting
PHASE3Ages 3–24InterventionalTreatment
Nemours Children's Clinic
~400 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation SolutionSodium Chloride 0.9% Inhl 3Ml

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Minimum Clinically Important Difference (Aim 1)
Measured over Immediately after the intervention
+1 more outcome measured

Conditions

Bronchiolitis
Bronchodilator Agents

Explore related trials

Bronchiolitis

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Andrea Rivera-Sepulveda, MD, MSc
[email protected]
407-489-6847
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Children between 3 to 24 months of age
Clinical diagnosis of bronchiolitis by the treating provider(s), defined by the American Academy of Pediatrics as a clinical syndrome involving lower respiratory tract symptoms
Children who either have no history of prematurity or have a history of prematurity but without associated co-morbidities
Emergency department (ED) visit to seek care at Nemours Children's Health-Florida (NCH-FL)

Exclusion

Patients previously enrolled in the PI's K12 study
Documented history of asthma or reactive airway disease
Co-morbidities affecting airway response (e.g., chronic lung disease, bronchopulmonary dysplasia, bronchiectasis, congenital heart disease, immunodeficiency, neurologic condition)
Diagnosis of pneumonia by chest radiography
Inhaled, nebulized, or oral corticosteroid use within 72 hours of ED evaluation
Inhaled, nebulized, or oral bronchodilator administration within 4 hours of ED arrival

What this trial measures

  • Minimum Clinically Important Difference (Aim 1)Immediately after the intervention

    Identify the minimum clinically important difference (MCID) in the modified Tal score (MTS) in children with bronchiolitis from parents/ caregivers and treating providers' perceived improvement in respiratory response. The minimum clinically important difference (MCID) is a 15-point scale, ranging from -7 (very much worse) to +7 (very much improved), as assessed by responses from the caregiver(s) and the treating provider(s). A response of +1 to +2 will be interpreted as a "small" perceived improvement in respiratory function. The modified Tal score (MTS) includes respiratory parameters documented as part of the ED standard of care. The MTS score ranges from 0 to 12 points, with higher scores indicating greater respiratory distress.

  • Candidate genetic variants (Aim 2)through study completion, an average of 1 year

    Identify candidate single nucleotide polymorphisms (SNPs), rank-ordered by the strength of their association with the modified Tal score (delta) respiratory score based on an odds ratio (dichotomous response) or a beta coefficient (continuous response) and filtered by adjusted p-value.