Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth (DOORWAY)
18 luglio 2014 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
1011
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Quebec, Canada, G1V 4G2
- Centre Hospitaliser de l'Université Laval
-
-
Ontario
-
London, Ontario, Canada, N6A 2V5
- Children's Hospital of London Health Sciences Centre
-
Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
-
-
Quebec
-
Montreal, Quebec, Canada, H3T1C5
- CHU Sainte-Justine (CHUSJ)
-
Montreal, Quebec, Canada, H3H 1P3
- Montreal Children's Hospital (MCH)
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 1 anno a 17 anni (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
Children aged 1 to 17 years with moderate to severe asthma with Pediatric Respiratory Assessment Measure (PRAM) ≥4.
Descrizione
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 :
- 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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
Oral corticosteroids (OCS)
All patients receive:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Hospital admission
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Length of active treatment in hospital
Lasso di tempo: 8 hours after oral corticosteroid administration
|
8 hours after oral corticosteroid administration
|
|
|
Meeting the severity criteria for admission
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Within 8 hours of oral corticosteroid administration
|
Time until PRAM score ≤ 3
|
Within 8 hours of oral corticosteroid administration
|
|
Change in respiratory resistance
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Adverse events
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Francine M Ducharme, MD., M.Sc., CHU Sainte Justine, University of Montreal
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2011
Completamento primario (Effettivo)
1 gennaio 2014
Completamento dello studio (Effettivo)
1 gennaio 2014
Date di iscrizione allo studio
Primo inviato
11 dicembre 2013
Primo inviato che soddisfa i criteri di controllo qualità
11 dicembre 2013
Primo Inserito (Stima)
17 dicembre 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
22 luglio 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 luglio 2014
Ultimo verificato
1 luglio 2014
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CHUSJ
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .