Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254)

August 12, 2024 updated by: Organon and Co

A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled, 2-Arm, 2X2 Crossover Study Comparing the Effects of Montelukast, Inhaled Budesonide, and Placebo on Lower Leg Growth in Children (Prepubertal, Tanner Stage I) With Mild Asthma

The purpose of this study is to determine the effect of montelukast, an approved medication, on the lower leg growth rate in children with mild asthma. The primary hypothesis is that the lower leg length (LLL) growth rate for children treated with montelukast compared to placebo will be established.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a crossover study that consists of a 2-week placebo run-in period, then a first 3-week treatment period, then a 2-week washout period, and then a second 3-week treatment period. Participants will be randomized to treatment with either montelukast and placebo or budesonide and placebo. The duration of treatment is 6 weeks.

Study Type

Interventional

Enrollment (Actual)

71

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

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A 6-month history of asthma with periodic episodes requiring treatment.

Exclusion Criteria:

  • Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.

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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Montelukast→Placebo
Participants receive one montelukast 5 mg chewable tablet once daily (QD) for 3 weeks. After a 2-week washout period, participants receive one placebo chewable tablet QD for 3 weeks.
Drug: Montelukast chewable tablets
Montelukast sodium 5 mg chewable tablets
Drug: Placebo to montelukast chewable tablets
Placebo chewable tablets
Experimental: Placebo→Montelukast
Participants receive one placebo chewable tablet QD for 3 weeks. After a 2-week washout period, participants receive one montelukast 5 mg chewable tablet QD for 3 weeks.
Drug: Montelukast chewable tablets
Montelukast sodium 5 mg chewable tablets
Drug: Placebo to montelukast chewable tablets
Placebo chewable tablets
Active Comparator: Budesonide→Placebo
Participants receive budesonide 200 mcg inhalation powder twice daily (BID) for 3 weeks. After a 2-week washout period, participants receive placebo inhalation powder BID for 3 weeks.
Drug: Budesonide inhaler
Budesonide 200 mcg inhalation powder
Drug: Placebo to budesonide inhaler
Placebo inhalation powder
Active Comparator: Placebo→Budesonide
Participants receive placebo inhalation powder BID for 3 weeks. After a 2-week washout period, participants receive budesonide 200 mcg inhalation powder BID for 3 weeks.
Drug: Budesonide inhaler
Budesonide 200 mcg inhalation powder
Drug: Placebo to budesonide inhaler
Placebo inhalation powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term lower-leg growth rate (LLGR)
Time Frame: Baseline and Week 3
Lower leg length was measured in millimeters (mm) using a knemometer.
Baseline and Week 3

Collaborators and Investigators

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

Sponsor

Organon and Co

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2002

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

September 21, 2004

First Submitted That Met QC Criteria

September 23, 2004

First Posted (Estimated)

September 24, 2004

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0476-254
  • 2004_023 (Other Identifier: Telerx ID Number)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

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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