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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Asthma, Bronchial

Intervention / Treatment
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* Drug: Montelukast chewable tablets
* Drug: Budesonide inhaler
* Drug: Placebo to montelukast chewable tablets
* Drug: Placebo to budesonide inhaler


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast→Placebo<br>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<br>* Montelukast sodium 5 mg chewable tablets<br>Drug: Placebo to montelukast chewable tablets<br>* Placebo chewable tablets<br>|
| Experimental: Placebo→Montelukast<br>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<br>* Montelukast sodium 5 mg chewable tablets<br>Drug: Placebo to montelukast chewable tablets<br>* Placebo chewable tablets<br>|
| Active Comparator: Budesonide→Placebo<br>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<br>* Budesonide 200 mcg inhalation powder<br>Drug: Placebo to budesonide inhaler<br>* Placebo inhalation powder<br>|
| Active Comparator: Placebo→Budesonide<br>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<br>* Budesonide 200 mcg inhalation powder<br>Drug: Placebo to budesonide inhaler<br>* Placebo inhalation powder<br>|

What is the study measuring?
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Primary Outcome Measures

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