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临床试验/NCT01770899
NCT01770899Unknown不适用

A Prospective Analysis of the Use of Oral Montelukast in Children With Status Asthmaticus

Corrie Fletcher1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Improvement of pediatric asthma score

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of oral montelukast (Singulair) given with other standard asthma medications and treatments in the treatment of children with status asthmaticus. Status asthmaticus is an acute asthma attack that does not respond to standard intermittent treatments but requires a continuous medication to aid in breathing. While new medications have been used to better manage chronic asthma, acute asthma exacerbations continue to be a significant cause of hospitalization and even death in children. Oral montelukast is a very safe medication that is used to manage chronic asthma in children, but it has not been studied for use in status asthmaticus. If oral montelukast, given with other standard therapies, can reduce the treatment length associated with severe, acute asthma exacerbations in children, it could potentially improve both the morbidity and burden of pediatric asthma.

详细描述

While new medications have been used to better manage chronic asthma, acute exacerbations continue to be a significant cause of pediatric morbidity and mortality. Montelukast holds an established role in the pediatric outpatient management of asthma and while two promising studies in adults have demonstrated its potential use as an adjunctive therapy for acute exacerbations, its similar use in pediatrics has yet to be established. This pilot study is designed as a prospective, double blinded, randomized, controlled, clinical trial comparing the use of oral montelukast plus standard of care vs. standard of care alone in children admitted for status asthmaticus to the pediatric intensive care unit (PICU). The primary outcome the investigators are interested in is the time to reach a Modified Pediatric Asthma Score (PAS) of < 5, which, per the clinical protocol for the treatment of status asthmaticus, is the time when patients are able to come off continuous bronchodilator therapy. If oral montelukast, given with other standard therapies, can reduce the treatment, emotional, and financial burden (e.g., shortened intensive care stay) associated with severe, acute asthma exacerbations in children, it would provide a significant therapeutic advantage, potentially improving both the morbidity and burden of pediatric asthma.

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
2 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Montelukast

Experimental

Montelukast 5mg capsules for 2-5 year old every 24h and 8mg capsules for 6-14 year olds every 24h.

干预措施: Montelukast (Drug)

Placebo

Placebo Comparator

One placebo capsule given every 24h

干预措施: Placebo (Drug)

结局指标

主要结局

Improvement of pediatric asthma score

时间窗: Hourly during the length of the patient's pediatric ICU hospitalization for status asthmaticus

Measurement of pediatric asthma score hourly from admission assessing for time to improvement of score, an average length of stay predicted 2-4 days.

次要结局

未报告次要终点

研究者

发起方
Corrie Fletcher
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Corrie Fletcher

Pediatric Resident

Advocate Center for Pediatric Research

研究点 (1)

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