A Randomised Trial of Single Dose Oral Dexamethasone versus Multi-Dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in children who attend the Emergency Department

niversity College Dublin Clinical Research Centre0 个研究点目标入组 232 人开始时间: 2010年8月5日最近更新: 2012年10月22日

适应症

试验速览

暂无简介。

•Ages 2 – 16 years
•Background history of asthma.
•Asthma for the purpose of this study will be defined as either: at least one previous episode of ß2-agonist-responsive wheeze in a child two years of age or over; or a prior diagnosis of asthma, made by a paediatrician, or clinician of comparable experience.
•Presentation with an asthma exacerbation
•An exacerbation of asthma, for the purpose of this study, will be defined as acute asthma which prompts assessment at the Emergency Department, and has any, or all, of the following clinical features:
•o Acute cough
•o Increased work of breathing
•o Increased requirement for ß2-agonist from baseline use
•o SpO2 <95%
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 232
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Less than 2 years old or over 16 years
•Critical or life-threatening asthma, defined as patients displaying one or more of the following clinical features:
•o Confused/drowsy
•o Maximal accessory muscle use/recession
•o Poor respiratory effort (including bradypnoea)
•o Exhaustion
•o Silent chest
•o O2 saturation < 90% in air
•o Marked tachycardia
•o Unable to verbalise normally
•o Pneumothorax
•Known TB exposure
•Active varicella or herpes simplex infection
•Documented concurrent infection with RSV
•Fever >39.5 degrees Celcius
•Use of oral corticosteroids in the previous 4 weeks
•Concurrent stridor
•Significant co-morbid disease:
•Lung, cardiac, immune, liver, endocrine, neurological or psychiatric

发起方

niversity College Dublin Clinical Research Centre