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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: Recruiting Phase 2 study of Status Asthmaticus, sponsored by Vanderbilt University Medical Center.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Peak montelukast plasma level
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 |
What NCT05819541 shows while recruiting
NCT05819541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05819541's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,199 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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