Linear Growth Study (0476-097)(COMPLETED)

Organon

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks; Drug: MK0476, montelukast sodium / Duration of Treatment : 56 Weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395408

2006_550

0476-097

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind