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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 4 Study of Oral Montelukast Hospitalized Preschool Children

Conditions
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Acute Asthma, Acute Wheezy Bronchitis

Intervention / Treatment
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* Drug: Montelukast 4 Mg Oral Granule
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Montelukast<br>Children received 4 mg oral montelukast granule daily until discharge. | Drug: Montelukast 4 Mg Oral Granule<br> <br> * Other names: Montelukast sodium;|
| Placebo Comparator: Placebo<br>Children receive 4 mg oral placebo montelukast granule daily until discharge | Drug: Placebos<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | The primary outcome was the difference in mean length of hospital stay as an hour between the 2 groups. | within the 5 days from hospitalization | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute asthma, Montelukast, Hospitalized children, Preschool children