Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254)
A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled, 2-Arm, 2X2 Crossover Study Comparing the Effects of Montelukast, Inhaled Budesonide, and Placebo on Lower Leg Growth in Children (Prepubertal, Tanner Stage I) With Mild Asthma
2 other identifiers
interventional
71
0 countries
N/A
Brief Summary
The purpose of this study is to determine the effect of montelukast, an approved medication, on the lower leg growth rate in children with mild asthma. The primary hypothesis is that the lower leg length (LLL) growth rate for children treated with montelukast compared to placebo will be established.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2002
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 21, 2004
CompletedFirst Posted
Study publicly available on registry
September 24, 2004
CompletedAugust 14, 2024
February 1, 2022
1.7 years
September 21, 2004
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Short-term lower-leg growth rate (LLGR)
Lower leg length was measured in millimeters (mm) using a knemometer.
Baseline and Week 3
Study Arms (4)
Montelukast→Placebo
EXPERIMENTALParticipants receive one montelukast 5 mg chewable tablet once daily (QD) for 3 weeks. After a 2-week washout period, participants receive one placebo chewable tablet QD for 3 weeks.
Placebo→Montelukast
EXPERIMENTALParticipants receive one placebo chewable tablet QD for 3 weeks. After a 2-week washout period, participants receive one montelukast 5 mg chewable tablet QD for 3 weeks.
Budesonide→Placebo
ACTIVE COMPARATORParticipants receive budesonide 200 mcg inhalation powder twice daily (BID) for 3 weeks. After a 2-week washout period, participants receive placebo inhalation powder BID for 3 weeks.
Placebo→Budesonide
ACTIVE COMPARATORParticipants receive placebo inhalation powder BID for 3 weeks. After a 2-week washout period, participants receive budesonide 200 mcg inhalation powder BID for 3 weeks.
Interventions
Montelukast sodium 5 mg chewable tablets
Placebo chewable tablets
Eligibility Criteria
You may qualify if:
- A 6-month history of asthma with periodic episodes requiring treatment.
You may not qualify if:
- Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
Pedersen S, Agertoft L, Williams-Herman D, Kuznetsova O, Reiss TF, Knorr B, Dass SB, Wolthers OD. Placebo-controlled study of montelukast and budesonide on short-term growth in prepubertal asthmatic children. Pediatr Pulmonol. 2007 Sep;42(9):838-43. doi: 10.1002/ppul.20666.
PMID: 17659605BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2004
First Posted
September 24, 2004
Study Start
October 1, 2002
Primary Completion
June 1, 2004
Study Completion
June 1, 2004
Last Updated
August 14, 2024
Record last verified: 2022-02