Linear Growth Study

Condition(s) targeted: Asthma

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

Phase: Phase 3

Status: Completed

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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:

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

Minimum age: 6 Years. Maximum age: 8 Years. Gender(s): Both.

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

Related publications:

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.

Starting date: June 2000
Last updated: January 10, 2007