NCT06946264 Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features
| NCT ID | NCT06946264 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Nemours Children's Clinic |
| Condition | Bronchiolitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2022-07-08 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2022-07-08 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06946264 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 24 Months, studying Bronchiolitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06946264 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT06946264 currently recruiting?
Yes, NCT06946264 is actively recruiting participants. Contact the research team at andrea.rivera-sepulveda@nemours.org for enrollment information.
Where is the NCT06946264 trial being conducted?
This trial is being conducted at Orlando, United States.
Who is sponsoring the NCT06946264 clinical trial?
NCT06946264 is sponsored by Nemours Children's Clinic. The trial plans to enroll 400 participants.