Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254)
Phase 4
Completed
- Conditions
- Asthma, Bronchial
- Interventions
- Drug: Placebo to budesonide inhaler
- Registration Number
- NCT00092092
- Lead Sponsor
- Organon and Co
- 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.
- Detailed Description
This is a crossover study that consists of a 2-week placebo run-in period, then a first 3-week treatment period, then a 2-week washout period, and then a second 3-week treatment period. Participants will be randomized to treatment with either montelukast and placebo or budesonide and placebo. The duration of treatment is 6 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
Inclusion Criteria
- A 6-month history of asthma with periodic episodes requiring treatment.
Exclusion Criteria
- Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo→Montelukast Placebo to montelukast chewable tablets Participants 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 Budesonide inhaler Participants 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. Budesonide→Placebo Placebo to budesonide inhaler Participants 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 Budesonide inhaler Participants 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. Placebo→Budesonide Placebo to budesonide inhaler Participants 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. Montelukast→Placebo Placebo to montelukast chewable tablets Participants 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 Montelukast chewable tablets Participants 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. Montelukast→Placebo Montelukast chewable tablets Participants 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.
- Primary Outcome Measures
Name Time Method Short-term lower-leg growth rate (LLGR) Baseline and Week 3 Lower leg length was measured in millimeters (mm) using a knemometer.
- Secondary Outcome Measures
Name Time Method