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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092092

Enrollment

Registered

2004-09-24

Start date

2002-10-31

Completion date

2004-06-30

Last updated

2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Bronchial

Brief 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.

Interventions

DRUGMontelukast chewable tablets

Montelukast sodium 5 mg chewable tablets

DRUGBudesonide inhaler

Budesonide 200 mcg inhalation powder

DRUGPlacebo to montelukast chewable tablets

Placebo chewable tablets

DRUGPlacebo to budesonide inhaler

Placebo inhalation powder

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Years to 11 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026