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Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth (DOORWAY)

2014年7月18日 更新者：Professor Francine Ducharme、St. Justine's Hospital
The aim of the prospective cohort study is to: (1) document the magnitude of response to oral corticosteroids administered to children presenting to the emergency department with moderate or severe asthma and (2) quantify clinically available potential determinants of the response to corticosteroids, such as age, gender, triggers of the index exacerbation, environmental tobacco smoke (ETS), gene polymorphisms, and their interactions.

研究概览

地位

完全的

条件

详细说明

The objective of the large multicentre cohort study is to quantify the response to oral corticosteroids in children aged 1 to 17 years presenting to the ED with a moderate or severe asthma exacerbation.

The main outcome is hospital admission within 72 hours of the oral corticosteroid administration.

Secondary outcomes include the change in Pediatric Respiratory Assessment Measure (PRAM), length of active treatment and other markers of response to therapy in the ED as well as markers of recovery over the next 10 days.

研究类型

观察性的

注册 (实际的)

1011

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
      • Quebec、加拿大、G1V 4G2
        • Centre Hospitaliser de l'Université Laval
    • Ontario
      • London、Ontario、加拿大、N6A 2V5
        • Children's Hospital of London Health Sciences Centre
      • Ottawa、Ontario、加拿大、K1H 8L1
        • Children's Hospital of Eastern Ontario
    • Quebec
      • Montreal、Quebec、加拿大、H3T1C5
        • CHU Sainte-Justine (CHUSJ)
      • Montreal、Quebec、加拿大、H3H 1P3
        • Montreal Children's Hospital (MCH)

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1年 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Children aged 1 to 17 years with moderate to severe asthma with Pediatric Respiratory Assessment Measure (PRAM) ≥4.

描述

Inclusion Criteria:

  • Subject will be eligible if he/she:

    1. is aged 1 to 17 years,
    2. has not received any oral, IM or IV corticosteroid within the last 5 days?
    3. Presents to the hospital emergency department with an acute episode of cough, wheezing and/or dyspnea?

    4. Has asthma as defined as one or more of the following 6 criteria:

      (i) prior diagnosis of asthma made by a physician; OR (ii) prior documented episode of acute cough, wheezing and/or dyspnea with significant response to inhaled β2-agonists or to oral corticosteroids; OR (iii) in a child aged <2 years, 3 or more episodes of cough, wheezing and/or dyspnea, including the index visit; OR (iv) previous lung function tests showing significant reversibility post-bronchodilation (≥12% FEV1 or ≥25% Rrs at 4 to 8 Hz); OR (v) a positive provocation test (PC20 ≤8 mg/mL or Provocation Dose (to increase Rrs by 50% or more (PD50) ≤8 mg/mL), OR (vi) the current episode diagnosed or suspected of asthma by the emergency physician?

    5. have moderate or severe airway obstruction, defined as a Paediatric Respiratory Asthma Measure (PRAM) score >3 at baseline,

Exclusion Criteria:

  • Patient will be excluded if :

    1. he/she has another chronic respiratory condition (such as bronchopulmonary dysplasia or cystic fibrosis);
    2. there is a reasonable suspicion of bronchiolitis or foreign body aspiration;
    3. he/she has a prior history of hypersensitivity to salbutamol, ipratropium bromide or oral prednisone/prednisolone;
    4. he/she has a relative or absolute contraindication to receiving oral corticosteroids such as recent exposure to varicella or live vaccine in past 14 days,
    5. there is confirmed or suspected pregnancy.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Oral corticosteroids (OCS)

All patients receive:

  1. Prednisone or Prednisolone at 1 mg/kg (in 1 site) or 2 mg/kg (in all other sites) (max. 50 mg); if vomiting prednisone/prednisolone: they receive dexamethasone (0.3 mg/kg, max. 10 mg)
  2. 2 to 3 doses of salbutamol within the first hour of therapy according to severity Those with severe exacerbations receive 3 treatments with salbutamol and ipratropium bromide within the initial hour of therapy.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Hospital admission
大体时间：72 hours after oral corticosteroids administration
Hospital admission or Length of active treatment for 8 or more hours after the oral corticosteroid administration or ED return visit associated with hospital admission within 72 hours after the oral corticosteroid administration or ED return visit associated within 72 hours with length of active treatment for 8 or more hours after the oral corticosteroid administration
72 hours after oral corticosteroids administration

次要结果测量

结果测量
措施说明
大体时间
Length of active treatment in hospital
大体时间：8 hours after oral corticosteroid administration
8 hours after oral corticosteroid administration
Meeting the severity criteria for admission
大体时间：Within 4 hours of oral corticosteroid administration
Proportion of children with a PRAM score ≥4 within 4 hours of oral corticosteroid administration
Within 4 hours of oral corticosteroid administration
PRAM profile in the ED
大体时间：Within 4 hours of oral corticosteroid administration
Area under the curve of the PRAM measured hourly for the time of oral corticosteroid (OCS) until 4 hours after OCS
Within 4 hours of oral corticosteroid administration
Time to meeting discharge criteria
大体时间：Within 8 hours of oral corticosteroid administration
Time until PRAM score ≤ 3
Within 8 hours of oral corticosteroid administration
Change in respiratory resistance
大体时间：Within 4 hours of oral corticosteroid administration
Change in respiratory resistance between baseline and disposition will be documented on the MasterScreen Impulse Oscillometry (Cardinal Health Canada, Montreal, Canada) using previously described standardized techniques in cooperative children aged ≥3 years. (measured in a subset of individuals)
Within 4 hours of oral corticosteroid administration
Unscheduled visits for asthma
大体时间：Within 7 days of the index ED exacerbation
unscheduled visits for asthma as reported by parents and confirmed by medical charts.
Within 7 days of the index ED exacerbation
Symptom score
大体时间：Within 7 days of the index ED exacerbation
Area under the curve of symptoms measured daily on the validated Asthma flare-up diary for children
Within 7 days of the index ED exacerbation
Duration of asthma symptoms
大体时间：Within 7 days of the index ED exacerbation
Duration of symptoms measured daily on the validated Asthma flare-up diary for children
Within 7 days of the index ED exacerbation
Cumulative reliever use
大体时间：Within 7 days of the index ED exacerbation
Cumulative number of puffs of reliever medication as recorded daily on the Asthma flare-up diary for children
Within 7 days of the index ED exacerbation
Duration of use of rescue ß2-agonists
大体时间：Within 7 days of the index ED exacerbation
Duration of use of rescue ß2-agonists as recorded on the Asthma flare-up diary for children
Within 7 days of the index ED exacerbation

其他结果措施

结果测量
措施说明
大体时间
Adverse events
大体时间：Within 7 days of the index ED exacerbation
Number of children with vomiting, serious Infection, psychosis, and mood disturbances
Within 7 days of the index ED exacerbation
Serious Adverse Health Events
大体时间：Within 7 days of the index ED exacerbation
Number of children with adverse events requiring hospitalization, prolonged hospitalization, life threatening, other medically important events or associated with significant disability or incapacity
Within 7 days of the index ED exacerbation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

St. Justine's Hospital

合作者

Canadian Institutes of Health Research (CIHR)

调查人员

  • 首席研究员：Francine M Ducharme, MD., M.Sc.、CHU Sainte Justine, University of Montreal

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年1月1日

初级完成 (实际的)

2014年1月1日

研究完成 (实际的)

2014年1月1日

研究注册日期

首次提交

2013年12月11日

首先提交符合 QC 标准的

2013年12月11日

首次发布 (估计)

2013年12月17日

研究记录更新

最后更新发布 (估计)

2014年7月22日

上次提交的符合 QC 标准的更新

2014年7月18日

最后验证

2014年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CHUSJ

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