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

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.

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Key information

Conditions

Asthma, Bronchial Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Montelukast chewable tablets

Drug

Montelukast sodium 5 mg chewable tablets

Budesonide inhaler

Drug

Budesonide 200 mcg inhalation powder

Placebo to montelukast chewable tablets

Drug

Placebo chewable tablets

Placebo to budesonide inhaler

Drug

Placebo inhalation powder

Primary outcomes

Short-term lower-leg growth rate (LLGR)

Time frame: Baseline and Week 3

Lower leg length was measured in millimeters (mm) using a knemometer.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2004
Study completion: 2004
First posted: Sep 24, 2004
Registry last updated: Aug 14, 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