Montelukast Added to Standard Therapy for Acute Asthma in Children Age 6-14 Years

Study Overview
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Brief Summary
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Oral montelukast is helpful in chronic asthma. The purpose of this pediatric study was to investigate whether the addition of oral montelukast to standard therapy for acute asthma exacerbations results in further improvement in breathing function over three hours.

Detailed Description
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We hypothesized that children with moderate acute asthma exacerbations receiving oral montelukast in addition to standard therapy will have at least 12% greater FEV1 improvement in three hours than those receiving standard therapy alone. In this randomized double-blind placebo-controlled study, we enrolled emergency patients aged 6-14 years with moderate acute asthma exacerbations (initial PEFR 40-70% predicted). Subjects received montelukast 5-mg or placebo orally then standard therapy consisting of weight-based doses of nebulized albuterol, nebulized ipratropium bromide, and oral corticosteroids. We measured FEV1 before study medication administration and hourly for three hours. We conducted a planned an interim analysis after approximately one-half of the estimated sample had been enrolled.

Official Title
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Randomized Controlled Trial of Oral Montelukast Added to Standard Therapy for Acute Asthma Exacerbations in Children Age 6 to 14 Years

Conditions
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Asthma

Intervention / Treatment
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* Drug: Montelukast 5-mg orally added to standard therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seeking care in ED for acute asthma exacerbation Age 6-14 years inclusive Initial FEV1 = 40-70% predicted (defined as moderate severity) Consent to participate in study Exclusion Criteria: Severe exacerbation requiring immediate therapy as determined by treating clinician Pregnancy by history Cystic Fibrosis by history Tuberculosis Gastroesophageal reflux disease requiring medications Acute or chronic liver disease Bronchopulmonary dysplasia Premature <34 weeks gestational age by history Having used leukotriene-modifying medication within 48 hours Having used theophylline within four weeks Unable to perform FEV1

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

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

| Intervention/Treatment |
| --- |
|Drug: Montelukast 5-mg orally added to standard therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in One Second (FEV1) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization Rate |  |  | 
| Relapse Visit Rate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute, Asthma, Child, Pediatric, Emergency, Oral, Montelukast, Forced Expiratory Volume in One Second, FEV1