Effect of Addition Oral Montelukast to Standard Treatment in Acute Asthma in Hospitalized Preschool Children

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.

Inclusion Criteria:

• Medical history of at least 4 wheezing attacks
• Children with the ages of 6-60 months
• Children whose parents accept to give written informed consent

Exclusion Criteria:

• Chronic diseases (e.g. malnutrition, anatomic malformation of the respiratory tract, chronic lung or heart disease, gastroesophageal reflux disease and cystic fibrosis)
• Children with a history of chronic drug use (e.g. antiepileptics and immune suppressives)