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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 71
- 主要终点
- Short-term lower-leg growth rate (LLGR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A 6-month history of asthma with periodic episodes requiring treatment.
排除标准
- •Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.
研究组 & 干预措施
Budesonide→Placebo
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.
干预措施: Budesonide inhaler (Drug)
Montelukast→Placebo
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.
干预措施: Placebo to montelukast chewable tablets (Drug)
Montelukast→Placebo
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.
干预措施: Montelukast chewable tablets (Drug)
Placebo→Montelukast
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.
干预措施: Montelukast chewable tablets (Drug)
Placebo→Montelukast
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.
干预措施: Placebo to montelukast chewable tablets (Drug)
Budesonide→Placebo
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.
干预措施: Placebo to budesonide inhaler (Drug)
Placebo→Budesonide
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.
干预措施: Budesonide inhaler (Drug)
Placebo→Budesonide
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.
干预措施: Placebo to budesonide inhaler (Drug)
结局指标
主要结局
Short-term lower-leg growth rate (LLGR)
时间窗: Baseline and Week 3
Lower leg length was measured in millimeters (mm) using a knemometer.
次要结局
未报告次要终点