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

Phase 4

Completed

• Conditions: Allergic Rhinitis; Asthma
• Interventions: Drug: montelukast sodium; Drug: inhaled corticosteroid

• Registration Number: NCT00442559
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2007-02-28
• Study First Submitted QC: 2007-02-28
• Study First Posted: 2007-03-02
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Results First Submitted: 2008-10-12
• Results First Submitted QC: 2008-11-10
• Results First Posted: 2008-11-18
• Status Verified: 2022-01
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Montelukast	montelukast sodium	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.
Inhaled Corticosteroids (ICS)	inhaled corticosteroid	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline for Daytime Asthma Symptom Score	Baseline and Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline for Daily Allergic Rhinitis Symptom Score	Baseline and Week 12	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.