Actively Recruiting
Treating Exacerbations of Asthma With Oral Montelukast in Children
Led by Vanderbilt University Medical Center · Updated on 2025-06-24
90
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Treating Exacerbations of Asthma With Oral Montelukast in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child aged 4 to 12 years with doctor-diagnosed asthma
- Presenting with moderate or severe acute asthma exacerbation (AAIRS >7) after initial inhaled albuterol treatment
- Parent agrees to follow-up by phone or mail at 2-3 weeks for questionnaires
You will not qualify if you...
- Gestational age less than 34 weeks
- Acute or chronic liver disease
- Allergy to montelukast
- Female with Tanner stage 2 or greater breast development
- Gastroesophageal reflux requiring acid-blocking medication
- History of anxiety disorder, depression, or other neuropsychiatric disorder except ADHD
- Positive response on questions 1 or 2 of Columbia Suicide Severity Rating Scale
- Score greater than 25 on the Screen for Child Anxiety Related Disorders (SCARED) questionnaire
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232-9001
Actively Recruiting
Research Team
D
Donald H Arnold, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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