Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,011
- 试验地点
- 5
- 主要终点
- Hospital admission
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject will be eligible if he/she:
- •is aged 1 to 17 years,
- •has not received any oral, IM or IV corticosteroid within the last 5 days?
- •Presents to the hospital emergency department with an acute episode of cough, wheezing and/or dyspnea?
- •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?
- •have moderate or severe airway obstruction, defined as a Paediatric Respiratory Asthma Measure (PRAM) score >3 at baseline,
排除标准
- •Patient will be excluded if :
- •he/she has another chronic respiratory condition (such as bronchopulmonary dysplasia or cystic fibrosis);
- •there is a reasonable suspicion of bronchiolitis or foreign body aspiration;
- •he/she has a prior history of hypersensitivity to salbutamol, ipratropium bromide or oral prednisone/prednisolone;
- •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,
- •there is confirmed or suspected pregnancy.
结局指标
主要结局
Hospital admission
时间窗: 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
次要结局
- Unscheduled visits for asthma(Within 7 days of the index ED exacerbation)
- Meeting the severity criteria for admission(Within 4 hours of oral corticosteroid administration)
- Length of active treatment in hospital(8 hours after oral corticosteroid administration)
- PRAM profile in the ED(Within 4 hours of oral corticosteroid administration)
- Time to meeting discharge criteria(Within 8 hours of oral corticosteroid administration)
- Cumulative reliever use(Within 7 days of the index ED exacerbation)
- Change in respiratory resistance(Within 4 hours of oral corticosteroid administration)
- Symptom score(Within 7 days of the index ED exacerbation)
- Duration of asthma symptoms(Within 7 days of the index ED exacerbation)
- Duration of use of rescue ß2-agonists(Within 7 days of the index ED exacerbation)
研究者
Professor Francine Ducharme
Professor
St. Justine's Hospital