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临床试验/NCT02802111
NCT02802111已完成不适用

Change in Oxygen Consumption Following Inhalation of Albuterol in Comparison With Levalbuterol in Healthy Adult Volunteers

Children's Hospital Los Angeles0 个研究点目标入组 24 人开始时间: 2015年6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
状态
已完成
入组人数
24
主要终点
Oxygen Consumption

研究概览

简要总结

Albuterol is the most commonly used β agonist to treat reversible lower airway obstruction. Albuterol contains a racemic mixture of two enantiomers. Levalbuterol contains the single R form enantiomer. Levalbuterol is frequently prescribed to limit cardiovascular toxicity. The investigators sought to examine the changes in oxygen consumption (V'O2) and Heart Rate (HR) following administration of albuterol and

详细描述

Inhaled β2 adrenoceptor agonists are frequently used to treat reversible lower airway obstruction, or to assist with mucociliary clearance. Albuterol remains the most commonly used β agonist and contains a racemic mixture of two enantiomers. The R enantiomer is the active moiety responsible for the bronchodilation, while the S enantiomer was initially thought to be inactive, although recent studies suggest otherwise. Levalbuterol contains the single R form enantiomer, and in clinical practice it is frequently prescribed not only because of its bronchodilator benefits, but to limit cardiovascular toxicity. Adverse cardiovascular effects remain the main dose-limiting factor for β2 agonists. The primary objective of the investigators study is to compare the change in oxygen consumption following albuterol to that of levalbuterol, in healthy adult volunteers. The investigators hypothesized there would be no clinically significant difference in V'O2 between the two drugs, if equal doses of the R-enantiomer were administered. Secondary objectives were to compare the changes in heart rate and other vital signs between the two drugs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers between the ages of 18 and 60 years

排除标准

  • Coronary artery disease, history of intolerance to beta agonists

研究组 & 干预措施

Albuterol 5 mg first, then levalbuterol 2.5 mg

Experimental

Patient receives albuterol 5 mg aerosolized first and then 4 hours or greater after receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.

干预措施: Albuterol (Drug)

Levalbuterol 2.5 mg first, then albuterol 5 mg

Experimental

Patient receives levalbuterol 2.5 mg aerosolized first and then 4 hours or greater after receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.

干预措施: Levalbuterol (Drug)

结局指标

主要结局

Oxygen Consumption

时间窗: 0 to 60 minutes

Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol

次要结局

  • Heart Rate(0 to 60 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patrick Ross

Associate Professor of Clinical Anesthesia and Pediatrics

Children's Hospital Los Angeles

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