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

This study is currently recruiting participants.
Verified December 2013 by St. Justine's Hospital
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: NA
Last verified: December 2013
History: No changes posted
  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 Intervention
Asthma
Drug: Oral Corticosteroids

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.


Estimated Enrollment: 1000
Study Start Date: January 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Oral corticosteroids (OCS)
Patient will receive 1 mg/kg (in 1 site) or 2 mg/kg (in all other sites) of Prednisone/Prednisolone (maximum 50 mg) or if vomiting OCS: 0.3 mg/kg of Dexamethasone (maximum 10 mg)
Drug: Oral Corticosteroids
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 of prednisone/prednisolone: dexamethasone (0.3 mg/kg, max. 10 mg) (2) 2 to 3 doses of salbutamol within the first hour of therapy. Those with severe exacerbations receive 3 treatments with salbutamol and ipratropium bromide within the initial hour of therapy.
Other Names:
  • Prednisone
  • Prednisolone
  • (Dexamethasone)

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

Contacts
Contact: Francine M Ducharme, MD, M.Sc. 1-5143454931 ext 4398 francine.m.ducharme@umontreal.ca
Contact: Bhupendrasinh Chauhan, Ph.D. 1-51453454931 ext 4997 bhupendrasinh.chauhan@recherche-ste-justine.qc.ca

Locations
Canada, Ontario
Children's Hospital of London Health Sciences Centre Completed
London, Ontario, Canada, N6A 2V5
Children's Hospital of Eastern Ontario Completed
Ottawa, Ontario, Canada, K1H 8L1
Canada, Quebec
CHU Sainte-Justine (CHUSJ) Recruiting
Montreal, Quebec, Canada, H3T1C5
Contact: Francine M Ducharem, MD, M.Sc.    1-5143454931 ext 4398    francine.m.ducharme@umontreal.ca   
Contact: Bhupendrasinh Chauhan, Ph.D.    1-5143454931 ext 4997    bhupendrasinh.chauhan@recherche-ste-justine.qc.ca   
Principal Investigator: Francine M Ducharme, MD, M.Sc.         
Montreal Children's Hospital (MCH) Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Dominic Chalut, MD    1-5144124400 ext 23039    dominic.chalut@muhc.mcgill.ca   
Contact: Dorothy McKelvey, CCRP    1-5149341934 ext 23833    Dorothy.McKelvey@MUHC.MCGILL.CA   
Principal Investigator: Dominic Chalut, MD         
Canada
Centre Hospitaliser de l'Université Laval Terminated
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: December 11, 2013
Health Authority: Canada: Canadian Institutes of Health Research

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dexamethasone acetate
Methylprednisolone acetate
Prednisolone acetate
Dexamethasone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisone
Dexamethasone 21-phosphate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 22, 2014