Personalized Medicine, Biomarker-based Study of Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- %FEV1
研究概览
简要总结
Our overall objective is to model a pediatric Acute Asthma Clinical Decision Rule (ADR) for personalized medicine by identification of treatment-response phenotypes that are important determinants of outcome. The Specific Aim of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.
详细描述
The objective of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Participants are randomized in randomly permuted blocks of four. Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Doctor diagnosed asthma
- •Acute asthma exacerbation
- •Treatment with systemic corticosteroids and nebulized albuterol
- •Ages 5 to 17 years
排除标准
- •Other acute or chronic lung disease
研究组 & 干预措施
Nebulized albuterol 10mg/hr continuous
Active control arm, 10mg/hr continuous.
干预措施: Albuterol (Drug)
10mg/hr pulsed
Experimental 10mg/hr pulsed albuterol regimen.
干预措施: Albuterol (Drug)
25mg/hr continuous
Experimental 25mg/hr continuous albuterol.
干预措施: Albuterol (Drug)
25mg/hr pulsed
Experimental 25mg/hr pulsed albuterol
干预措施: Albuterol (Drug)
结局指标
主要结局
%FEV1
时间窗: 2 hours
% predicted forced expiratory volume in 1-second as a measure of airway obstruction
次要结局
未报告次要终点
研究者
Donald H Arnold
Associate Professor of Pediatrics and Emergency Medicine
Vanderbilt University Medical Center