Treating Exacerbations of Asthma With Oral Montelukast in Children (TEAM)
Status Asthmaticus
About this trial
This is an interventional treatment trial for Status Asthmaticus
Eligibility Criteria
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.
Sites / Locations
- Monroe Carell Jr. Children's Hospital at Vanderbilt
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
High-dose oral montelukast plus standard treatment
Identical placebo plus standard treatment
Escalating dose-levels of oral montelukast between 2 mg/kg and 3 mg/kg determined by pharmacokinetic-guided dose modeling, added to standard, guideline-based treatment (systemic corticosteroid, inhaled albuterol, and possible treatment adjuncts such as IV magnesium, determined by evidence-based asthma clinical practice guideline).
Guideline-based treatment (systemic corticosteroid, inhaled albuterol, and possible treatment adjuncts such as IV magnesium, determined by evidence-based asthma clinical practice guideline).