NCT00092092

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Asthma, Bronchial

Interventions

Type	Name	Description
DRUG	Montelukast chewable tablets	Montelukast sodium 5 mg chewable tablets
DRUG	Budesonide inhaler	Budesonide 200 mcg inhalation powder
DRUG	Placebo to montelukast chewable tablets	Placebo chewable tablets
DRUG	Placebo to budesonide inhaler	Placebo inhalation powder

Timeline

• Start date: 2002-10-01
• Primary completion: 2004-06-01
• Completion: 2004-06-01
• First posted: 2004-09-24
• Last updated: 2024-08-14