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AsthmaDOORWAYNCT02013076

Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth

An observational study of Asthma, run by St. Justine's Hospital at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 year to 17 years
Conditions the study is for
Asthma
How many people
1,011 participants
Where
5 sitesCanada
Study dates
Jan 2011to Jan 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 17 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • Subject will be eligible if he/she:
  • is aged 1 to 17 years,
  • has not received any oral, IM or IV corticosteroid within the last 5 days?
  • Presents to the hospital emergency department with an acute episode of cough, wheezing and/or dyspnea?
  • Has asthma as defined as one or more of the following 6 criteria:
  • 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?
  • have moderate or severe airway obstruction, defined as a Paediatric Respiratory Asthma Measure (PRAM) score >3 at baseline,

Who cannot join

  • Patient will be excluded if :
  • he/she has another chronic respiratory condition (such as bronchopulmonary dysplasia or cystic fibrosis);
  • there is a reasonable suspicion of bronchiolitis or foreign body aspiration;
  • he/she has a prior history of hypersensitivity to salbutamol, ipratropium bromide or oral prednisone/prednisolone;
  • 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,
  • there is confirmed or suspected pregnancy.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Children's Hospital of London Health Sciences Centre

    London, Ontario, N6A 2V5

  • Montreal Children's Hospital (MCH)

    Montreal, Quebec, H3H 1P3

  • CHU Sainte-Justine (CHUSJ)

    Montreal, Quebec, H3T1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Centre Hospitaliser de l'Université Laval

    Québec, Quebec, G1V 4G2

Other trials in Canada

About this study

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.

Read the 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.

Conditions
Asthma
Keywords
Asthma; Children; Cohort study; Corticosteroids
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02013076
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospital admission

    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

    Measured: 72 hours after oral corticosteroids administration

Secondary outcomes (10)

  1. Length of active treatment in hospital

    Measured: 8 hours after oral corticosteroid administration

  2. Meeting the severity criteria for admission

    Proportion of children with a PRAM score ≥4 within 4 hours of oral corticosteroid administration

    Measured: Within 4 hours of oral corticosteroid administration

  3. PRAM profile in the ED

    Area under the curve of the PRAM measured hourly for the time of oral corticosteroid (OCS) until 4 hours after OCS

    Measured: Within 4 hours of oral corticosteroid administration

  4. Time to meeting discharge criteria

    Time until PRAM score ≤ 3

    Measured: Within 8 hours of oral corticosteroid administration

  5. Change in respiratory resistance

    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)

    Measured: Within 4 hours of oral corticosteroid administration

  6. Unscheduled visits for asthma

    unscheduled visits for asthma as reported by parents and confirmed by medical charts.

    Measured: Within 7 days of the index ED exacerbation

  7. Symptom score

    Area under the curve of symptoms measured daily on the validated Asthma flare-up diary for children

    Measured: Within 7 days of the index ED exacerbation

  8. Duration of asthma symptoms

    Duration of symptoms measured daily on the validated Asthma flare-up diary for children

    Measured: Within 7 days of the index ED exacerbation

  9. Cumulative reliever use

    Cumulative number of puffs of reliever medication as recorded daily on the Asthma flare-up diary for children

    Measured: Within 7 days of the index ED exacerbation

  10. Duration of use of rescue ß2-agonists

    Duration of use of rescue ß2-agonists as recorded on the Asthma flare-up diary for children

    Measured: Within 7 days of the index ED exacerbation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2013 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,011 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02013076
Sponsor's protocol ID
CHUSJ
Acronym
DOORWAY
Status last verified
Jul 2014
First submitted
11 Dec 2013
Last updated
22 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30644648

  • 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.

    PubMed 29866794

  • 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.

    PubMed 27451347

  • 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.

    PubMed 24710133

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by St. Justine's Hospital at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital admission (time frame: 72 hours after oral corticosteroids administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02013076, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2014.

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