Treating Exacerbations of Asthma With Oral Montelukast in Children (NCT05819541) | Clinical Trial Compass
CompletedPhase 2
Treating Exacerbations of Asthma With Oral Montelukast in Children
United States90 participantsStarted 2023-10-20
Plain-language 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 pre-treatment plasma leukotriene E4 (LTE4).
Who can participate
Age range
4 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Gestational age \< 34 weeks
* acute or chronic liver disease
* allergy to montelukast
* female with any evidence of Tanner stage 2 or greater breast development
* gastroesophageal reflux requiring acid-blocking medication
* history of anxiety disorder, depression and/or other neuropsychiatric disorder except ADHD
* positive on question 1 or 2 of the Columbia Suicide Severity Rating Scale (CSSR-S)
* score \>25 on the 82-point Screen for Child Anxiety Related Disorders (SCARED) questionnaire
* Patients currently receiving daily montelukast (4 or 5 mg) will not be excluded from study participation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial studying montelukast plasma levels in children with severe asthma attacks, what does that mean about how much is actually known so far about whether it's safe and effective for this purpose?
2This trial has already completed — has my doctor seen or can they access any published results showing what montelukast blood levels were achieved in children during a serious asthma episode?
3The trial focused on measuring how much montelukast gets into the bloodstream during a status asthmaticus episode — does that tell us anything useful about whether oral montelukast could actually help manage my child's severe asthma attacks going forward?
4How does oral montelukast compare to the standard treatments my child would already receive during a severe asthma episode, and would adding it change the current care plan in any meaningful way?
5Given that this trial studied children specifically, how does my child's age, weight, or severity of asthma factor into whether findings from this study would even apply to their situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.