Linear Growth Study (0476-097)(COMPLETED)

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Beclomethasone; Montelukast

Criteria

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