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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Professor Francine Ducharme, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT02013076
First received: December 11, 2013
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth

Resource links provided by NLM:


Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Hospital admission [ Time Frame: 72 hours after oral corticosteroids administration ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Length of active treatment in hospital [ Time Frame: 8 hours after oral corticosteroid administration ] [ Designated as safety issue: No ]
  • Meeting the severity criteria for admission [ Time Frame: Within 4 hours of oral corticosteroid administration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time until PRAM score ≤ 3

  • Change in respiratory resistance [ Time Frame: Within 4 hours of oral corticosteroid administration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Duration of use of rescue ß2-agonists as recorded on the Asthma flare-up diary for children


Other Outcome Measures:
  • Adverse events [ Time Frame: Within 7 days of the index ED exacerbation ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Number of children with adverse events requiring hospitalization, prolonged hospitalization, life threatening, other medically important events or associated with significant disability or incapacity


Biospecimen Retention:   Samples With DNA

Saliva for cotinine and for DNA and nasopharyngeal samples for viral analysis.


Enrollment: 1011
Study Start Date: January 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
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.

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.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013076

Locations
Canada, Ontario
Children's Hospital of London Health Sciences Centre
London, Ontario, Canada, N6A 2V5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Canada, Quebec
CHU Sainte-Justine (CHUSJ)
Montreal, Quebec, Canada, H3T1C5
Montreal Children's Hospital (MCH)
Montreal, Quebec, Canada, H3H 1P3
Canada
Centre Hospitaliser de l'Université Laval
Quebec, Canada, G1V 4G2
Sponsors and Collaborators
St. Justine's Hospital
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Francine M Ducharme, MD., M.Sc. CHU Sainte Justine, University of Montreal
  More Information

No publications provided

Responsible Party: Professor Francine Ducharme, Professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02013076     History of Changes
Other Study ID Numbers: CHUSJ
Study First Received: December 11, 2013
Last Updated: July 18, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by St. Justine's Hospital:
Asthma; Children; Cohort study; Corticosteroids

ClinicalTrials.gov processed this record on October 01, 2014