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NCT06946264 · ClinicalTrials.gov registry record · Phase 3
Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features
A Phase 3 study of Bronchiolitis and Bronchodilator Agents, sponsored by Nemours Children's Clinic.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 1
- Study location
NCT06946264 is a Phase 3 study of Bronchiolitis and Bronchodilator Agents that is actively recruiting participants, run by Nemours Children's Clinic. The registered enrollment target is 400 participants, below the 543-participant average among 12 other Bronchiolitis trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06946264, a Phase 3 study of Bronchiolitis and Bronchodilator Agents, is actively recruiting participants, sponsored by Nemours Children's Clinic.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 1
- Study location
Study 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 an
Conditions Studied
Interventions
- DRUG Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution
- DRUG Sodium Chloride 0.9% Inhl 3Ml
Study Locations (1)
Florida
- Nemours Children's Health - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2022-07-08 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06946264
The ClinicalTrials.gov registry entry for NCT06946264 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 543-participant average among 12 other Bronchiolitis trials with a reported enrollment target (26% lower). The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Bronchiolitis appearing as the primary indexed condition, and to 2 interventions - of which Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution is the first listed.
NCT06946264 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT06946264 about?
NCT06946264 is a clinical study titled "Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features". 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 in...
What is the current status of trial NCT06946264?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2022-07-08. Estimated completion is 2030-12-31.
What conditions does trial NCT06946264 study?
This clinical trial studies the following conditions: Bronchiolitis, Bronchodilator Agents.
What interventions are being tested in trial NCT06946264?
The interventions under investigation include: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution (DRUG), Sodium Chloride 0.9% Inhl 3Ml (DRUG).
Who is sponsoring clinical trial NCT06946264?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06946264 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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