Treating Exacerbations of Asthma With Oral Montelukast in Children

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).

Eligibility

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.

Conditions2

Locations1 site

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