Recruiting
Phase 3

Bronchodilator Response

Sponsor:

Nemours Children's Clinic

Code:

NCT06946264

Conditions

Bronchiolitis

Bronchodilator Agents

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution

Sodium Chloride 0.9% Inhl 3Ml

Study Details

Brief summary:

Bronchiolitis is the leading cause of pediatric morbidity and healthcare costs. Despite the commonplace use of bronchodilator treatments, like albuterol, in conditions like asthma, their efficacy in bronchiolitis remains controversial due to the heterogeneity in patient response. Although studies indicate that bronchodilators do not enhance outcomes in bronchiolitis, meta-analyses can obscure the heterogeneity of treatment effects. While bronchodilator response genetics have not been explored in bronchiolitis, treatment effectiveness variations often depend on genomic factors. Genome-wide association studies (GWAS) have linked genetic variants with bronchodilator response and outcomes in childhood asthma, suggesting a bronchodilator-responsive genotype. This proposal aims to extend this paradigm to bronchiolitis, addressing the gap in knowledge where GWAS and clinical characteristics intersect. The proposed study's objective is to characterize phenotypic and genotypic variations of children with bronchiolitis and their association with bronchodilator response. We hypothesize that children with bronchiolitis who exhibit clinical and historical characteristics associated with atopy and specific physical findings have genetic variants linked to bronchodilator response. To achieve this, we propose to (Aim 1) define airway responsiveness to bronchodilator treatment in children with bronchiolitis using the change in respiratory score, (Aim 2a) identify the associations between candidate genetic variants and bronchodilator response among children with bronchiolitis, and (Aim 2b) determine the associations between candidate genetic variants and clinical patient data to identify bronchodilator-responsive children with bronchiolitis. A prospective, double-blind, randomized, placebo-controlled trial of a single albuterol dose in children aged 3 to 24 months presenting with bronchiolitis to the emergency department will be conducted to achieve these aims. Patient information and respiratory assessment outcomes will be collected before and after intervention. Blood, urine, DNA buccal swabs, and nasopharyngeal swabs will also be collected. Completion of these aims will result in a novel clinical prediction model for bronchodilator response determination in bronchiolitis, integrating clinical, physical, and genetic data. Furthermore, this research supports the candidates' career development goals of advancing training in clinical trial research design and execution and becoming an expert in clinical and translational methods to enhance pediatric emergency department health and outcomes. Ultimately, this work will inform an R01 application to validate an evidence-based prediction rule for identifying bronchodilator-responsive children with bronchiolitis through a multi-center emergency medicine research network, optimizing therapeutic approaches, and reducing resource use in those with a low likelihood of bronchodilator response.

Conditions

Bronchiolitis

Bronchodilator Agents

Study ID

NCT06946264

Start date

Jul 8, 2022

Status verified date

May, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bronchodilator arm

Children with bronchiolitis will be randomized to an intervention arm to be administered as a nebulization (albuterol sulfate 2.5mg/ 3mL inhalation solution). The intervention drug will be placed in a sealed manila envelope, randomized in advance by a Nemours Investigational Drug Pharmacist, and stored in the ED pyxis.

placebo comparator: Normal saline arm

Children with bronchiolitis will be randomized to an intervention arm to be administered as a nebulization (sodium chloride 0.9%/ 3mL inhalation solution). The intervention drug will be placed in a sealed manila envelope, randomized in advance by a Nemours Investigational Drug Pharmacist, and stored in the ED pyxis.

Interventions

Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution

Children with bronchiolitis will be randomized to an intervention arm to be administered as a nebulization (albuterol sulfate 2.5mg/ 3mL inhalation solution). The intervention drug will be placed in a sealed manila envelope, randomized in advance by a Nemours Investigational Drug Pharmacist, and stored in the ED pyxis.

Sodium Chloride 0.9% Inhl 3Ml

Children with bronchiolitis will be randomized to an intervention arm to be administered as a nebulization (sodium chloride 0.9% 3mL inhalation solution). The intervention drug will be placed in a sealed manila envelope, randomized in advance by a Nemours Investigational Drug Pharmacist, and stored in the ED pyxis.

Primary outcome measure

  • Minimum Clinically Important Difference (Aim 1) [ Time Frame: Immediately after the intervention ]
  • Candidate genetic variants (Aim 2) [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Andrea Rivera-Sepulveda, MD, MSc

407-489-6847andrea.rivera-sepulveda@nemours.org

Locations

Nemours Children's Health

Recruiting

Orlando, Florida, United States, 32827

More Information

Sponsor

Nemours Children's Clinic

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • double-blind randomized clinical trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2026-05-08.