Acute Asthma Clinical Trial
Official title:
Phase 4 Study of Oral Montelukast Hospitalized Preschool Children
Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient
asthma. Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor
antagonist with a rapid onset of action.However, there is very little information as to their
role in acute asthma exacerbations.
The purpose of this study is to determine if adding oral montelukast to the maximal standard
treatment in children hospitalized for acute asthma has any additive benefit.
Background: Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor
antagonist with a rapid onset of action.
Objective: To evaluate the effect of the addition of a single dose of oral montelukast to
standard therapy in acute asthma. Design: Double-blind, randomised, controlled, parallel
group trial. Setting: Pediatric service of Education and training Hospital Patients: Children
with the ages of 6-60 months who were hospitalized for acute asthma Intervention: Children
received montelukast 4 mg or placebo orally in addition to the standard therapy. Clinical
asthma score was recorded before administering study medication and thereafter, 4 hourly
until discharge. Main outcome measure: The primary outcome was discharge rates.
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