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Sponsor: Vanderbilt University Medical Center
Conditions: Status Asthmaticus
Interventions: Montelukast Oral Granules, Albuterol, Corticosteroid
Countries: United States
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).
Sex: ALL
Age: 4 Years to 12 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Nashville, Tennessee, United States