Understanding how genetics affect bronchodilator response in children with bronchiolitis
Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features
PHASE3 · Nemours Children's Clinic · NCT06946264
This study is testing how genetics might affect how well bronchodilator treatments work for young children with bronchiolitis.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 3 Months to 24 Months |
| Sex | All |
| Sponsor | Nemours Children's Clinic (other) |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT06946264 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 24 months with a clinical diagnosis of bronchiolitis.
Not a fit: Patients with a history of asthma, significant co-morbidities, or recent corticosteroid or bronchodilator use may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Orlando, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bronchiolitis, Bronchodilator Agents, double-blind randomized clinical trial