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NCT05819541 · ClinicalTrials.gov registry record · Phase 2
Treating Exacerbations of Asthma With Oral Montelukast in Children
A Phase 2 study of Status Asthmaticus, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT05819541 is a Phase 2 study of Status Asthmaticus that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 90 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05819541, a Phase 2 study of Status Asthmaticus, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
This research will establish a mg/kg dose for a future RCT to determine the efficacy of high-dose oral montelukast for children with moderate and severe acute asthma exacerbations. Aim: Perform an adaptive, double-masked randomized controlled trial (RCT) of high-dose oral montelukast, with escalating mg/kg dose levels determined by PK-guided dose modeling, added to standard treatment versus standard treatment alone, in children with exacerbations that are moderate or severe after initial treatment with inhaled albuterol. Hypothesis 1: High-dose oral montelukast achieves peak plasma concentration (Cmax) \>1,700 ng/ml in \>86% of at least one of three sequential participant groups with escalating weight-based (milligram/kilogram or mg/kg) doses between groups. Hypothesis 2: Participants randomized to high-dose oral montelukast have a 2 point or greater improvement of the validated Acute Asthma Intensity Research Score (AAIRS) at 4 hours post-treatment in comparison with control group participants. Hypothesis 3: Among montelukast recipients, Cmax correlates with change of the AAIRS at 4 hours, after adjustment for pre-treatment exacerbation severity and systemic leukotriene stress measured using urinary leukotriene E4 (LTE4).
Conditions Studied
Interventions
- DRUG Corticosteroid
- DRUG Montelukast Oral Granules
- DRUG Albuterol
Study Locations (1)
Tennessee
- Monroe Carell Jr. Children's Hospital at Vanderbilt - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-10-20 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05819541
The ClinicalTrials.gov registry entry for NCT05819541 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Status Asthmaticus appearing as the primary indexed condition, and to 3 interventions - of which Corticosteroid is the first listed.
NCT05819541 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT05819541 about?
NCT05819541 is a clinical study titled "Treating Exacerbations of Asthma With Oral Montelukast in Children". This research will establish a mg/kg dose for a future RCT to determine the efficacy of high-dose oral montelukast for children with moderate and severe acute asthma exacerbations. Aim: Perform an adaptive, double-masked randomized controlled trial (RCT) of high-dose oral montelukast, with escalati...
What is the current status of trial NCT05819541?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2023-10-20. Estimated completion is 2026-06-30.
What conditions does trial NCT05819541 study?
This clinical trial studies the following conditions: Status Asthmaticus.
What interventions are being tested in trial NCT05819541?
The interventions under investigation include: Corticosteroid (DRUG), Montelukast Oral Granules (DRUG), Albuterol (DRUG).
Who is sponsoring clinical trial NCT05819541?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05819541 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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