Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)

Study Overview
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Brief Summary
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The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.

Official Title
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Korean Study of Real-World Montelukast Use in Mild Asthmatic Children With Concomitant Allergic Rhinitis

Conditions
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Asthma, Allergic Rhinitis

Intervention / Treatment
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* Drug: montelukast sodium
* Drug: inhaled corticosteroid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 2 and 14 years old Diagnosed with asthma, classified as mild persistent asthma according to Global Initiative Asthma Guidelines (GINA) Diagnosed with comorbid allergic rhinitis Exclusion Criteria: Patients with suspected sinus infection Prior treatment with high dose inhaled corticosteroid requiring a dose higher than beclomethasone dipropionate 400 ug per day, or equivalent, other medications used in severe cases

Ages Eligible for Study
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Minimum Age: 2 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast<br>Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. | Drug: montelukast sodium<br>* Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months<br>* Other names: Singulair, MK0476;|
| Active Comparator: Inhaled Corticosteroids (ICS)<br>Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. | Drug: inhaled corticosteroid<br>* Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline for Daytime Asthma Symptom Score | The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline for Daily Allergic Rhinitis Symptom Score | The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome. | Baseline and Week 12 |