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

Organon and Co191 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

191

Conditions

Asthma Allergic Rhinitis

Interventions

montelukast sodiumDRUG

Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months

inhaled corticosteroidDRUG

Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months

Eligibility

Sex: ALLMin age: 2 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Week 12

Secondary Outcomes

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.

Time frame: Baseline and Week 12

Data from ClinicalTrials.gov

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