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

18. juli 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1011

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hospital admission
Tidsramme: 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

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse events
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

St. Justine's Hospital

Samarbejdspartnere

Canadian Institutes of Health Research (CIHR)

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2011

Primær færdiggørelse (Faktiske)

1. januar 2014

Studieafslutning (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først indsendt

11. december 2013

Først indsendt, der opfyldte QC-kriterier

11. december 2013

Først opslået (Skøn)

17. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juli 2014

Sidst verificeret

1. juli 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHUSJ

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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