Effect of Addition of Single Dose of Oral Montelukast to Standard Treatment in Acute Asthma in Preschool Children.

Study Overview
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Brief Summary
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The purpose of this study is to determine if adding single dose of oral montelukast to the standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for treatment of acute wheezing provide additional clinical benefit in the emergency room.

Detailed Description
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Systemic corticosteroids and short acting beta-2 agonists are the mainstay treatment of acute asthma, however, little data exists regarding use of leukotriene antagonists in acute asthma. A few studies in adults have shown that oral montelukast also improved pulmonary function when being added to the standard treatment. But in school-age children this clinical benefit could not be demonstrated by adding montelukast to the standard treatment of acute asthma in emergency room. Moreover in preschool children there are no studies on this topic. The investigators hypothesized that addition of single dose of oral montelukast to standard therapy in acute moderate to severe wheezing may provide additional benefit in the meaning of improvement of pulmonary score and/or proportion of discharge from emergency department in preschool-age children.

Official Title
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Phase 4 Study of Single Dose of Oral Montelukast When Adding to Standard Treatment in Acute Moderate to Severe Wheezing in Preschool Children.

Conditions
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Asthma, Acute Asthma

Intervention / Treatment
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* Drug: montelukast 4 mg granule
* Drug: Montelukast placebo granüle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6 months to 6 years of age With at least three episodes of wheezing in the previous 12 months Who presented to the ED with a moderate to severe wheezing episode (defined as a Pulmonary Index Score [PIS] of 7 to 13 Exclusion Criteria: Patients who were receiving more than 400 mcg of inhaled budesonide or equivalent per day Who had any change in their dose of ICSs in the past 2 months Who had taken systemic corticosteroid within 1 months Patients who have concurrent pneumonia, croup or suspected foreign body aspiration, a history of cystic fibrosis, bronchopulmonary dysplasia, bronchiolitis obliterans, congenital heart disease, liver or renal disease,sickle cell anemia or immune deficiency were excluded.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1-Montelukast<br>Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids. | Drug: montelukast 4 mg granule<br>* Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.<br>|
| Placebo Comparator: 2- Placebo<br>Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids. | Drug: Montelukast placebo granüle<br>* Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.<br>* Other names: Montelukast placebo granule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of pulmonary index score from baseline to 120 minutes. | İmprovment of pulmonary index score from 0 to 120 minutes was compared bwtween the montelukast and placebo groups. | 0 to 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of discharge from emergency department. | Proportion of subjects who were discharged from emergency department at 120,180 and 240. minutes were compared between the montelukast and placebo groups. | 120, 180 and 240. minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute asthma, Children, Montelukast, Emergency room