Clinical trial NCT02013076: Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth
Official title: Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma; Children; Cohort study; Corticosteroids
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-12-17
Enrollment: 1011
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 1 to 17 years with moderate to severe asthma with Pediatric Respiratory Assessment Measure (PRAM) ≥4.

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.

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.

Primary outcomes:
measure: Hospital admission
timeFrame: 72 hours after oral corticosteroids administration
Secondary outcomes:
measure: Length of active treatment in hospital
timeFrame: 8 hours after oral corticosteroid administration
measure: Meeting the severity criteria for admission
timeFrame: Within 4 hours of oral corticosteroid administration
measure: PRAM profile in the ED
timeFrame: Within 4 hours of oral corticosteroid administration
measure: Time to meeting discharge criteria
timeFrame: Within 8 hours of oral corticosteroid administration
measure: Change in respiratory resistance
timeFrame: Within 4 hours of oral corticosteroid administration
measure: Unscheduled visits for asthma
timeFrame: Within 7 days of the index ED exacerbation
measure: Symptom score
timeFrame: Within 7 days of the index ED exacerbation
measure: Duration of asthma symptoms
timeFrame: Within 7 days of the index ED exacerbation
measure: Cumulative reliever use
timeFrame: Within 7 days of the index ED exacerbation
measure: Duration of use of rescue ß2-agonists
timeFrame: Within 7 days of the index ED exacerbation
Other outcomes:
measure: Adverse events
timeFrame: Within 7 days of the index ED exacerbation
measure: Serious Adverse Health Events
timeFrame: Within 7 days of the index ED exacerbation
Locations:
city: London
country: Canada
facility: Children's Hospital of London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Montreal
country: Canada
facility: Montreal Children's Hospital (MCH)
state: Quebec
city: Montreal
country: Canada
facility: CHU Sainte-Justine (CHUSJ)
state: Quebec
city: Quebec
country: Canada
facility: Centre Hospitaliser de l'Université Laval
Study officials:
affiliation: CHU Sainte Justine, University of Montreal
name: Francine M Ducharme, MD., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tse SM, Krajinovic M, Chauhan BF, Zemek R, Gravel J, Chalut D, Poonai N, Quach C, Laberge S, Ducharme FM; DOORWAY research group of the Pediatric Emergency Research in Canada (PERC) network. Genetic determinants of acute asthma therapy response in children with moderate-to-severe asthma exacerbations. Pediatr Pulmonol. 2019 Apr;54(4):378-385. doi: 10.1002/ppul.24247. Epub 2019 Jan 15.
citation: Merckx J, Ducharme FM, Martineau C, Zemek R, Gravel J, Chalut D, Poonai N, Quach C; Pediatric Emergency Research Canada (PERC) DOORWAY team. Respiratory Viruses and Treatment Failure in Children With Asthma Exacerbation. Pediatrics. 2018 Jul;142(1):e20174105. doi: 10.1542/peds.2017-4105. Epub 2018 Jun 4.
citation: Ducharme FM, Zemek R, Chauhan BF, Gravel J, Chalut D, Poonai N, Guertin MC, Quach C, Blondeau L, Laberge S; DOORWAY research group of the Pediatric Emergency Research in Canada (PERC) network. Factors associated with failure of emergency department management in children with acute moderate or severe asthma: a prospective, multicentre, cohort study. Lancet Respir Med. 2016 Dec;4(12):990-998. doi: 10.1016/S2213-2600(16)30160-6. Epub 2016 Jul 20.
citation: Ducharme FM, Zemek R, Gravel J, Chalut D, Poonai N, Laberge S, Quach C, Krajinovic M, Guimont C, Lemiere C, Guertin MC. Determinants Of Oral corticosteroid Responsiveness in Wheezing Asthmatic Youth (DOORWAY): protocol for a prospective multicentre cohort study of children with acute moderate-to-severe asthma exacerbations. BMJ Open. 2014 Apr 7;4(4):e004699. doi: 10.1136/bmjopen-2013-004699.