Linear Growth Study (0476-097)(COMPLETED)
Phase 4
Completed
- Conditions
- Asthma
- Registration Number
- NCT00395408
- Lead Sponsor
- Organon and Co
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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