NCT05819541CompletedPhase 2
Treating Exacerbations of Asthma With Oral Montelukast in Children
Dose Escalation Clinical Trial of High-dose Oral Montelukast to Inform Future RCT in Children With Acute Asthma Exacerbations
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
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 pre-treatment plasma leukotriene E4 (LTE4).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 24 Mar 2023
- Start date
- 20 Oct 2023
- Primary completion date
- 26 Mar 2026
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Asthma
- NCT number
- NCT05819541
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 90
- From 20 Oct 2023 to the primary completion date, 26 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- gastroesophageal reflux requiring acid-blocking medication
- Patients currently receiving daily montelukast (4 or 5 mg) will not be excluded from study participation.
Other illness
- acute or chronic liver disease
- allergy to montelukast
- history of anxiety disorder, depression and/or other neuropsychiatric disorder except ADHD
- score \>25 on the 82-point Screen for Child Anxiety Related Disorders (SCARED) questionnaire
Age
- Gestational age \< 34 weeks
Other
- female with any evidence of Tanner stage 2 or greater breast development
- positive on question 1 or 2 of the Columbia Suicide Severity Rating Scale (CSSR-S)
Who the study is looking for
- Child aged 4 - 12 years with doctor-diagnosed asthma
- Presents to the Vanderbilt Children's Hospital with an acute asthma exacerbation that is moderate or severe (AAIRS \>7) after initial treatment with inhaled albuterol
- The parent agrees to phone and/or mail follow-up at 2-3 weeks for completion of SCARED and side-effect questionnaires.
Age in the registry: 4 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monroe Carell Jr. Children's Hospital at Vanderbilt Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.