A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing the Effect on Linear Growth of Montelukast With Placebo and Inhaled Beclomethasone in Pediatric Patients (Prepubertal, Tanner Stage I) With Mild Asthma

Organon and Co0 sites360 target enrollmentJune 2000

ConditionsAsthma

DrugsMK0476, montelukast sodium / Duration of Treatment : 56 Weeks Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Asthma
Sponsor: Organon and Co
Enrollment: 360
Primary Endpoint: 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
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2000

End Date

December 2003

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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

Discontinuations due to asthma
Peripheral blood eosinophil count
Oral corticosteroid rescues for asthma
Markers of bone turn-over
To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1
Beta-agonist use