Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral corticosteroids (OCS) | All patients receive:
|
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Hospital admission | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of active treatment in hospital | 8 hours after oral corticosteroid administration | |
| Meeting the severity criteria for admission | Proportion of children with a PRAM score ≥4 within 4 hours of oral corticosteroid administration |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of children with vomiting, serious Infection, psychosis, and mood disturbances | Within 7 days of the index ED exacerbation |
| Serious Adverse Health Events | Number of children with adverse events requiring hospitalization, prolonged hospitalization, life threatening, other medically important events or associated with significant disability or incapacity |
Inclusion Criteria:
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,
Exclusion Criteria:
Patient will be excluded if :
Not provided
Not provided
Children aged 1 to 17 years with moderate to severe asthma with Pediatric Respiratory Assessment Measure (PRAM) ≥4.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francine M Ducharme, MD., M.Sc. | CHU Sainte Justine, University of Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of London Health Sciences Centre | London | Ontario | N6A 2V5 | Canada | ||
| Children's Hospital of Eastern Ontario |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30644648 | Derived | Tse SM, Krajinovic M, Chauhan BF, Zemek R, Gravel J, Chalut D, Poonai N, Quach C, Laberge S, Ducharme FM; DOORWAY research group of the Pediatric Emergency Research in Canada (PERC) network. Genetic determinants of acute asthma therapy response in children with moderate-to-severe asthma exacerbations. Pediatr Pulmonol. 2019 Apr;54(4):378-385. doi: 10.1002/ppul.24247. Epub 2019 Jan 15. | |
| 29866794 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Saliva for cotinine and for DNA and nasopharyngeal samples for viral analysis.
| Within 4 hours of oral corticosteroid administration |
| PRAM profile in the ED | 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 | Time until PRAM score ≤ 3 | Within 8 hours of oral corticosteroid administration |
| Change in respiratory resistance | 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 | unscheduled visits for asthma as reported by parents and confirmed by medical charts. | Within 7 days of the index ED exacerbation |
| Symptom score | 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 | 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 | 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 | 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 |
| Within 7 days of the index ED exacerbation |
| Ottawa |
| Ontario |
| K1H 8L1 |
| Canada |
| Montreal Children's Hospital (MCH) | Montreal | Quebec | H3H 1P3 | Canada |
| CHU Sainte-Justine (CHUSJ) | Montreal | Quebec | H3T1C5 | Canada |
| Centre Hospitaliser de l'Université Laval | Québec | Quebec | G1V 4G2 | Canada |
| Derived |
| Merckx J, Ducharme FM, Martineau C, Zemek R, Gravel J, Chalut D, Poonai N, Quach C; Pediatric Emergency Research Canada (PERC) DOORWAY team. Respiratory Viruses and Treatment Failure in Children With Asthma Exacerbation. Pediatrics. 2018 Jul;142(1):e20174105. doi: 10.1542/peds.2017-4105. Epub 2018 Jun 4. |
| 27451347 | Derived | Ducharme FM, Zemek R, Chauhan BF, Gravel J, Chalut D, Poonai N, Guertin MC, Quach C, Blondeau L, Laberge S; DOORWAY research group of the Pediatric Emergency Research in Canada (PERC) network. Factors associated with failure of emergency department management in children with acute moderate or severe asthma: a prospective, multicentre, cohort study. Lancet Respir Med. 2016 Dec;4(12):990-998. doi: 10.1016/S2213-2600(16)30160-6. Epub 2016 Jul 20. |
| 24710133 | Derived | Ducharme FM, Zemek R, Gravel J, Chalut D, Poonai N, Laberge S, Quach C, Krajinovic M, Guimont C, Lemiere C, Guertin MC. Determinants Of Oral corticosteroid Responsiveness in Wheezing Asthmatic Youth (DOORWAY): protocol for a prospective multicentre cohort study of children with acute moderate-to-severe asthma exacerbations. BMJ Open. 2014 Apr 7;4(4):e004699. doi: 10.1136/bmjopen-2013-004699. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |