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...
Date First Received: November 1, 2006
Last Updated: January 10, 2007
Verified by: Merck, January 2007
Clinical Trial Phase: Phase 3 | Start Date: June 2000
Overall Status: Completed
Estimated Enrollment: 300
Brief Summary
Official Title: “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”
Condition Keyword(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0476, montelukast sodium / Duration of Treatment : 56 Weeks
- Drug: Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1
- Beta-agonist use
- Oral corticosteroid rescues for asthma
- Discontinuations due to asthma
- Peripheral blood eosinophil count
- Markers of bone turn-over
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Years
Maximum Age for this Clinical Trial: 8 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
Becker AB, Kuznetsova O, Vermeulen J, Soto-Quiros ME, Young B, Reiss TF, Dass SB, Knorr BA; Pediatric Montelukast Linear Growth Study Group. Linear growth in prepubertal asthmatic children treated with montelukast, beclomethasone, or placebo: a 56-week randomized double-blind study. Ann Allergy Asthma Immunol. 2006 Jun;96(6):800-7.
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00395408
Study ID Number: 2006_550
ClinicalTrials.gov Identifier: NCT00395408
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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