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

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ClinicalTrials.gov Identifier: NCT02013076
Recruitment Status : Completed
First Posted : December 17, 2013
Last Update Posted : July 22, 2014
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Professor Francine Ducharme, St. Justine's Hospital

Tracking Information
First Submitted Date December 11, 2013
First Posted Date December 17, 2013
Last Update Posted Date July 22, 2014
Study Start Date January 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 11, 2013)
Hospital admission [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 11, 2013)
  • Length of active treatment in hospital [ Time Frame: 8 hours after oral corticosteroid administration ]
  • Meeting the severity criteria for admission [ Time Frame: Within 4 hours of oral corticosteroid administration ]
    Proportion of children with a PRAM score ≥4 within 4 hours of oral corticosteroid administration
  • PRAM profile in the ED [ Time Frame: 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
  • Time to meeting discharge criteria [ Time Frame: Within 8 hours of oral corticosteroid administration ]
    Time until PRAM score ≤ 3
  • Change in respiratory resistance [ Time Frame: 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)
  • Unscheduled visits for asthma [ Time Frame: Within 7 days of the index ED exacerbation ]
    unscheduled visits for asthma as reported by parents and confirmed by medical charts.
  • Symptom score [ Time Frame: 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
  • Duration of asthma symptoms [ Time Frame: Within 7 days of the index ED exacerbation ]
    Duration of symptoms measured daily on the validated Asthma flare-up diary for children
  • Cumulative reliever use [ Time Frame: 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
  • Duration of use of rescue ß2-agonists [ Time Frame: 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 11, 2013)
  • Adverse events [ Time Frame: Within 7 days of the index ED exacerbation ]
    Number of children with vomiting, serious Infection, psychosis, and mood disturbances
  • Serious Adverse Health Events [ Time Frame: 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth
Official Title Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth
Brief Summary 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.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Saliva for cotinine and for DNA and nasopharyngeal samples for viral analysis.
Sampling Method Probability Sample
Study Population Children aged 1 to 17 years with moderate to severe asthma with Pediatric Respiratory Assessment Measure (PRAM) ≥4.
Condition Asthma
Intervention Not Provided
Study Groups/Cohorts 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 18, 2014)
1011
Original Estimated Enrollment
 (submitted: December 11, 2013)
1000
Actual Study Completion Date January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02013076
Other Study ID Numbers CHUSJ
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Professor Francine Ducharme, St. Justine's Hospital
Study Sponsor St. Justine's Hospital
Collaborators Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Francine M Ducharme, MD., M.Sc. CHU Sainte Justine, University of Montreal
PRS Account St. Justine's Hospital
Verification Date July 2014