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

18 juli 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

1011

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
      • 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)

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

1 jaar tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hospital admission
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Length of active treatment in hospital
Tijdsspanne: 8 hours after oral corticosteroid administration
8 hours after oral corticosteroid administration
Meeting the severity criteria for admission
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Within 8 hours of oral corticosteroid administration
Time until PRAM score ≤ 3
Within 8 hours of oral corticosteroid administration
Change in respiratory resistance
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adverse events
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

St. Justine's Hospital

Medewerkers

Canadian Institutes of Health Research (CIHR)

Onderzoekers

  • Hoofdonderzoeker: Francine M Ducharme, MD., M.Sc., CHU Sainte Justine, University of Montreal

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2011

Primaire voltooiing (Werkelijk)

1 januari 2014

Studie voltooiing (Werkelijk)

1 januari 2014

Studieregistratiedata

Eerst ingediend

11 december 2013

Eerst ingediend dat voldeed aan de QC-criteria

11 december 2013

Eerst geplaatst (Schatting)

17 december 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

22 juli 2014

Laatste update ingediend die voldeed aan QC-criteria

18 juli 2014

Laatst geverifieerd

1 juli 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CHUSJ

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