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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03369119

Enrollment

100

Registered

2017-12-11

Start date

2011-08-31

Completion date

2012-12-31

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Asthma, Acute Wheezy Bronchitis

Keywords

Acute asthma, Montelukast, Hospitalized children, Preschool children

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.

Interventions

DRUGMontelukast 4 Mg Oral Granule

DRUGPlacebos

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Months to 60 Months

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Difference in clinical asthma score	Within 72 hours from hospitalization	Improvement of clinical asthma scores between the 2 groups within 72 hours

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026