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Completed

NCT Number: NCT02013076

Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth

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.

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Key information

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of London Health Sciences Centre, London, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

(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?

  • 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 :
  • 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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Length of active treatment in hospital

    Time frame: 8 hours after oral corticosteroid administration

  2. 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

  3. 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

  4. Time to meeting discharge criteria

    Time frame: Within 8 hours of oral corticosteroid administration

    Time until PRAM score ≤ 3

  5. 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)

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

Other outcomes

  1. Adverse events

    Time frame: Within 7 days of the index ED exacerbation

    Number of children with vomiting, serious Infection, psychosis, and mood disturbances

  2. 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

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Acronym: DOORWAY

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 17, 2013
Registry last updated
Jul 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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