NCT03369119

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

Phase 4 Study of Oral Montelukast Hospitalized Preschool Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Kecioren Education and Training Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 60 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Asthma
• Acute Wheezy Bronchitis

Interventions

Type	Name	Description
DRUG	Montelukast 4 Mg Oral Granule
DRUG	Placebos

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2017-12-11
• Last updated: 2017-12-11

Locations

1 site across 1 country: Turkey (Türkiye)