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

January 31, 2022 updated by: Organon and Co

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

191

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Montelukast
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
Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months
Other Names:
  • Singulair, MK0476
Active Comparator: Inhaled Corticosteroids (ICS)
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
Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 28, 2007

First Submitted That Met QC Criteria

February 28, 2007

First Posted (Estimate)

March 2, 2007

Study Record Updates

Last Update Posted (Actual)

February 25, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0476-367
  • 2007_003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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