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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Allergic Rhinitis Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

montelukast sodium

Drug

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

Other names: Singulair, MK0476

Inhaled corticosteroid

Drug

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

Primary outcomes

Change From Baseline for Daytime Asthma Symptom Score

Time frame: 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 outcomes

Change From Baseline for Daily Allergic Rhinitis Symptom Score

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Mar 2, 2007
Registry last updated: May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed