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

Phase 4

Completed

• Conditions: Acute Asthma; Acute Wheezy Bronchitis
• Interventions: Drug: Placebos; Drug: Montelukast 4 Mg Oral Granule

• Registration Number: NCT03369119
• Lead Sponsor: Kecioren Education and Training Hospital

Brief 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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Study First Submitted: 2017-11-30
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-05
• Last Update Submitted: 2017-12-05
• Study First Posted: 2017-12-11
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Children receive 4 mg oral placebo montelukast granule daily until discharge
Montelukast	Montelukast 4 Mg Oral Granule	Children received 4 mg oral montelukast granule daily until discharge.

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	within the 5 days from hospitalization	The primary outcome was the difference in mean length of hospital stay as an hour between the 2 groups.

Secondary Outcome Measures

Name	Time	Method
Difference in clinical asthma score	Within 72 hours from hospitalization	Improvement of clinical asthma scores between the 2 groups within 72 hours

Trial Locations

Locations (1)

Kecioren Education and Training Hospital; 🇹🇷 Ankara, Keçiören, Turkey