Understanding how genetics affect bronchodilator response in children with bronchiolitis
Official title: Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features
Run by Nemours Children's Clinic · NCT06946264 · Data updated 2026-11-12
This study is testing how genetics might affect how well bronchodilator treatments work for young children with bronchiolitis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 3 Months to 24 Months |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 1 site (Orlando, Florida) |
| Status | Recruiting |
| Started | July 8, 2022 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2030 |
| Registry record updated | May 8, 2026 |
| Trial ID | NCT06946264 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 3 to 24 months with a clinical diagnosis of bronchiolitis.
✕Probably not a fit
Patients with a history of asthma, significant co-morbidities, or recent corticosteroid or bronchodilator use may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the response to bronchodilator treatments, specifically albuterol, in children diagnosed with bronchiolitis. It aims to explore the phenotypic and genotypic variations that may influence treatment effectiveness, addressing the inconsistencies observed in previous studies. By focusing on children aged 3 to 24 months, the research will analyze genetic factors that could predict bronchodilator response, potentially leading to more personalized treatment approaches. The study will be conducted at Nemours Children's Health in Florida, utilizing a double-blind randomized design to ensure robust results.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatments for children with bronchiolitis, improving patient outcomes.
How similar studies have gone: While bronchodilator efficacy in bronchiolitis has been debated, genetic factors influencing treatment response have shown promise in related studies, suggesting potential for success in this novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Nemours Children's Health
Orlando, Florida, United States Recruiting
Study contacts
- Study coordinator: Andrea Rivera-Sepulveda, MD, MSc
- Email: andrea.rivera-sepulveda@nemours.org
- Phone: 407-489-6847
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.