Linear Growth Study (0476-097)(COMPLETED)
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
2 other identifiers
interventional
360
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Jun 2000
Longer than P75 for phase_4 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 1, 2006
CompletedFirst Posted
Study publicly available on registry
November 2, 2006
CompletedAugust 14, 2024
February 1, 2022
3.5 years
November 1, 2006
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Patients who used more than 2 courses of inhaled corticosteroids within the 12 months prior to Visit 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related 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. doi: 10.1016/s1081-1206(10)61342-7.
PMID: 16802767BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2006
First Posted
November 2, 2006
Study Start
June 1, 2000
Primary Completion
December 1, 2003
Study Completion
December 1, 2003
Last Updated
August 14, 2024
Record last verified: 2022-02