Linear Growth Study (0476-097)(COMPLETED)

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395408
• Other study ID #: 0476-097
• Secondary ID: 2006_550
• Status: Completed
• Phase: Phase 4
• Start date: June 2000
• Est. completion date: December 2003

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• MK0476, montelukast sodium / Duration of Treatment : 56 Weeks

• Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1
Secondary	Beta-agonist use
Secondary	Oral corticosteroid rescues for asthma
Secondary	Discontinuations due to asthma
Secondary	Peripheral blood eosinophil count
Secondary	Markers of bone turn-over