A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Percentage of days without asthma
研究概览
简要总结
A study to determine the effects of montelukast (MK-0476) on pediatric participants with chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of treatment, montelukast will provide at least the same level of asthma control as inhaled fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of treatment, daily administration of montelukast will be safe and well tolerated in children aged 6 months to 5 years with chronic asthma.
This trial was stopped at a time before any participants had actually entered the trial. Based on input from regulatory agencies, it is not necessary to conduct this study; a separate ongoing study was sufficient for regulatory purposes.
详细描述
This study consists of a 4-week placebo run-in period followed by a 24-week double-blind treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 6 months and 5 years, 4 months of age
- •Diagnosed with asthma by a doctor
- •At least 3 episodes of asthma symptoms within the last 6 months
排除标准
- •Active or chronic breathing disease, other than asthma
- •Required insertion of a breathing tube for asthma
- •Major surgery within the last 4 weeks
- •Currently in the hospital
- •Allergic to certain drugs, and for children under 2 years of age, apples, applesauce and formula
研究组 & 干预措施
Montelukast
Participants receive montelukast 4 mg oral granules (OG) or 4 mg chewable tablets (CT) once daily (QD) for 24 weeks and placebo to fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks. Participants aged >6 months to <2 years receive montelukast 4 mg packet of OG QD for 24 weeks. Participants aged >2 years to <64 months receive montelukast 4 mg CT QD for 24 weeks.
干预措施: Montelukast sodium (Drug)
Montelukast
Participants receive montelukast 4 mg oral granules (OG) or 4 mg chewable tablets (CT) once daily (QD) for 24 weeks and placebo to fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks. Participants aged >6 months to <2 years receive montelukast 4 mg packet of OG QD for 24 weeks. Participants aged >2 years to <64 months receive montelukast 4 mg CT QD for 24 weeks.
干预措施: Placebo to fluticasone (Drug)
Fluticasone
Participants receive fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks and placebo to montelukast 4 mg QD for 24 weeks. Participants aged >6 months to <2 years receive placebo packet of OG QD for 24 weeks. Participants aged >2 years to <64 months receive placebo CT QD for 24 weeks.
干预措施: Placebo to montelukast (Drug)
Fluticasone
Participants receive fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks and placebo to montelukast 4 mg QD for 24 weeks. Participants aged >6 months to <2 years receive placebo packet of OG QD for 24 weeks. Participants aged >2 years to <64 months receive placebo CT QD for 24 weeks.
干预措施: Fluticasone propionate (Drug)
结局指标
主要结局
Percentage of days without asthma
时间窗: 24 weeks
A day without asthma is defined as a day with all of the following: no daytime symptoms, no nighttime cough, no β-agonist use, and no asthma attack (defined as a visit to a doctor, urgent care clinic, emergency room, or hospital for asthma \[other than a scheduled visit to a doctor\], or treatment with systemic corticosteroid during the previous 24 hours).
Number of participants who discontinue study drug due to an AE
时间窗: Up to 24 weeks
Number of participants who experience at least one adverse event (AE)
时间窗: Up to 26 weeks
次要结局
- Percentage of days without daytime symptoms(24 weeks)
- Percentage of days without nighttime cough(24 weeks)
- Percentage of days without β-agonist use(24 weeks)