Status:
COMPLETED
Linear Growth Study (0476-097)(COMPLETED)
Lead Sponsor:
Organon and Co
Conditions:
Asthma
Eligibility:
All Genders
6-8 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00395408
Start Date
June 1 2000
End Date
December 1 2003
Last Update
August 14 2024
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