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

Phase 4CompletedNCT00092092

Organon and Co71 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Asthma, Bronchial

Interventions

Montelukast chewable tabletsDRUG

Montelukast sodium 5 mg chewable tablets

Budesonide inhalerDRUG

Budesonide 200 mcg inhalation powder

Placebo to montelukast chewable tabletsDRUG

Placebo chewable tablets

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Short-term lower-leg growth rate (LLGR)

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

Time frame: Baseline and Week 3

Data from ClinicalTrials.gov

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