Asthma Clinical Trial
Official title:
Phase 4 Study of Single Dose of Oral Montelukast When Adding to Standard Treatment in Acute Moderate to Severe Wheezing in Preschool Children.
The purpose of this study is to determine if adding single dose of oral montelukast to the standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for treatment of acute wheezing provide additional clinical benefit in the emergency room.
Systemic corticosteroids and short acting beta-2 agonists are the mainstay treatment of
acute asthma, however, little data exists regarding use of leukotriene antagonists in acute
asthma. A few studies in adults have shown that oral montelukast also improved pulmonary
function when being added to the standard treatment. But in school-age children this
clinical benefit could not be demonstrated by adding montelukast to the standard treatment
of acute asthma in emergency room. Moreover in preschool children there are no studies on
this topic.
The investigators hypothesized that addition of single dose of oral montelukast to standard
therapy in acute moderate to severe wheezing may provide additional benefit in the meaning
of improvement of pulmonary score and/or proportion of discharge from emergency department
in preschool-age children.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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