Linear Growth Study (0476-097)(COMPLETED)

Organon and Co360 enrolled

Overview

The purpose of this study is to compare the effect of montelukast with placebo and beclomethasone on the average rate of linear growth over a period of 56 weeks in children with mild asthma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

360

Conditions

Asthma

Interventions

MK0476, montelukast sodium / Duration of Treatment : 56 WeeksDRUG

Comparator : beclomethasone dipropionate / Duration of Treatment : 56 WeeksDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 8 Years

Medical Language ↔ Plain English

Inclusion Criteria : * Boys (aged 6 to 8 years at Visit 1) at Tanner Stage I (prepuberty) * Girls (aged 6 to 7 years at Visit 1) at Tanner Stage I (prepuberty * With at least a 6-month history of asthma with typical symptoms (including, but not limited to cough, wheeze, and shortness of breath, with periodic episodes requiring treatment with inhaled beta-agonists) Exclusion Criteria : * Patients who used more than 2 courses of inhaled corticosteroids within the 12 months prior to Visit 1

Outcomes

Primary Outcomes

To establish the difference in the average rate of linear growth over the 56-week double-blind treatment period between the montelukast and placebo groups

Secondary Outcomes

To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1

Beta-agonist use

Oral corticosteroid rescues for asthma

Discontinuations due to asthma

Peripheral blood eosinophil count

Markers of bone turn-over

Data from ClinicalTrials.gov

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