Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations
Status:
Not yet recruiting
Trial end date:
2023-09-05
Target enrollment:
Participant gender:
Summary
Objective: To determine the extent to which high-dose (30mg) oral montelukast, added to
standard treatment in children with moderate and severe acute exacerbations improves
outcomes.
Central Hypothesis: High-dose oral montelukast, added to standard treatment in children aged
5 to 17 years with moderate and severe acute asthma exacerbations, rapidly improves lung
function, clinical severity, hospitalization rate and 72-hour symptom burden.
Secondary Hypotheses:
1. There are greater effects of high-dose oral montelukast on lung function and on the
secondary outcomes in the presence of respiratory viral detection or
leukotriene-mediated inflammation; and
2. There is an interaction between viral detection and urinary leukotriene 4 level with
treatment-response.
Design: A two-arm, parallel randomized controlled trial of high-dose oral montelukast versus
identical placebo, as add-on to standard treatment of systemic corticosteroid (SCS) and
inhaled short-acting Beta-2-agonist (SABA), in children aged 5 to 17 years with moderate and
severe acute asthma exacerbations.
Intervention: High-dose oral montelukast added to standard treatment as one
treatment-allocation arm, in comparison with standard treatment as the 2nd
treatment-allocation arm.
Primary and Important Secondary Endpoints: For the Primary Aim, the primary outcome measure
to be compared between arms will be change of %-predicted airway resistance by impulse
oscillometry (IOS) at 5Hz (%R5) at 2 hours after treatment initiation. Secondary outcomes
will include improvement of %-predicted FEV1 (%FEV1), clinical severity measured using the
validated Acute Asthma Intensity Research Score (AAIRS), hospitalization rate, and 72 hour
symptom burden using the Pediatric Asthma Caregiver Diary (PACD). For the Secondary Aim, the
investigators will determine (1) The effects of high-dose oral montelukast on lung function
and on our secondary outcomes in the presence of nasal viruses and of greater
leukotriene-mediated inflammation; and (2) The degree of interaction between viral detection
and urinary leukotriene E4 (LTE4) level with treatment-response.
Laboratory evaluations: The primary outcome (change of %R5) and select secondary outcomes
(%FEV1, AAIRS, LTE4) will be measured before and again at 2 hours after treatment initiation.
The other secondary outcomes will be measured at the time of hospitalization decision-making
by the clinical team (hospitalization rate) or at 72-hours after treatment initiation (PACD).