Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth (DOORWAY)
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|ClinicalTrials.gov Identifier: NCT02013076|
Recruitment Status : Completed
First Posted : December 17, 2013
Last Update Posted : July 22, 2014
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|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||1011 participants|
|Official Title:||Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Oral corticosteroids (OCS)
All patients receive:
- 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
- Length of active treatment in hospital [ Time Frame: 8 hours after oral corticosteroid administration ]
- 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
- 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
- Time to meeting discharge criteria [ Time Frame: Within 8 hours of oral corticosteroid administration ]Time until PRAM score ≤ 3
- 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)
- 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.
- 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
- 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
- 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
- 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
- Adverse events [ Time Frame: Within 7 days of the index ED exacerbation ]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 ]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
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|Ages Eligible for Study:||1 Year to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
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,
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013076
|Children's Hospital of London Health Sciences Centre|
|London, Ontario, Canada, N6A 2V5|
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H 8L1|
|Montreal Children's Hospital (MCH)|
|Montreal, Quebec, Canada, H3H 1P3|
|CHU Sainte-Justine (CHUSJ)|
|Montreal, Quebec, Canada, H3T1C5|
|Centre Hospitaliser de l'Université Laval|
|Quebec, Canada, G1V 4G2|
|Principal Investigator:||Francine M Ducharme, MD., M.Sc.||CHU Sainte Justine, University of Montreal|
|Responsible Party:||Professor Francine Ducharme, Professor, St. Justine's Hospital|
|Other Study ID Numbers:||
|First Posted:||December 17, 2013 Key Record Dates|
|Last Update Posted:||July 22, 2014|
|Last Verified:||July 2014|
Asthma; Children; Cohort study; Corticosteroids
Signs and Symptoms, Respiratory