- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02013076
Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth (DOORWAY)
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
-
Quebec, Kanada, G1V 4G2
- Centre Hospitaliser de l'Université Laval
-
-
Ontario
-
London, Ontario, Kanada, N6A 2V5
- Children's Hospital of London Health Sciences Centre
-
Ottawa, Ontario, Kanada, K1H 8L1
- Children's Hospital of Eastern Ontario
-
-
Quebec
-
Montreal, Quebec, Kanada, H3T1C5
- CHU Sainte-Justine (CHUSJ)
-
Montreal, Quebec, Kanada, H3H 1P3
- Montreal Children's Hospital (MCH)
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
---|
Oral corticosteroids (OCS)
All patients receive:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Hospital admission
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Length of active treatment in hospital
Časové okno: 8 hours after oral corticosteroid administration
|
8 hours after oral corticosteroid administration
|
|
Meeting the severity criteria for admission
Časové okno: 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
Časové okno: 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
Časové okno: Within 8 hours of oral corticosteroid administration
|
Time until PRAM score ≤ 3
|
Within 8 hours of oral corticosteroid administration
|
Change in respiratory resistance
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Adverse events
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Francine M Ducharme, MD., M.Sc., CHU Sainte Justine, University of Montreal
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CHUSJ
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .