Determinants Of Oral corticosteroid Responsiveness in Wheezing Asthmatic Youth
The main objective is to identify and quantify clinically available factors (e.g., age, specific viral trigger, ETS) associated with hospital admission and other markers of clinical response to oral corticosteroids in preschool and school-aged children presenting to the ED with moderate or severe asthma.
- Start Year
- 2011
- End Year
- 2013
Visit DOORWAY
| Investigators | Contacts |
|---|---|
|
|
Design
- Study design
- Cohort
- Follow Up
-
10 days follow up to gather information on asthma control, quality of life and 10 day follow up for revisit of emergency department.
- Supplementary Information
-
Parents, legal guardians or care giver were allowed to respond several CRFs in the study.
Marker Paper
Ducharme F, et al. 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;4:e004699
PUBMED 24710133
Recruitment
- Recruitment Target
-
- Individuals
Number of Participants
- Number of Participants
- 975
- Number of Participants with Biological Samples
- 968
- Supplementary Information
-
From 975 enrolled patients:
Patients provided DNA samples: 906 samples
Patients provided Cotinine samples: 930 samples
Patients provided nasopharyngeal samples: 968 samples
Patients provided sputum samples: 11 samples
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
Timeline
Children with acute asthma
Children aged 1 to 17 years visiting one of five pediatric emergency departments namely CHU Ste-Justine, Montreal Children's Hospital, CHU de Laval, Children's Hospital of Eastern Ontario, Children’s Hospital of London Health Sciences Centre with a moderate or severe asthma exacerbation (PRAM score ≥4).
Selection Criteria
- Minimum age
-
1
- Maximum age
-
17
- Newborns
- Twins
- Countries
-
- Canada
- Territory
-
Montreal, Quebec, Ottawa and London
- Ethnic Origin
-
- Health Status
-
- Moderate to severe asthma exacerbation
- Other Criteria
-
Participants were eligible if they: (1) were aged 1–17 years; (2) had asthma, defined as: (i) prior diagnosis of asthma made by a physician; (ii) prior documented episode of acute cough, wheezing and/or dyspnoea with significant response to inhaled β2-agonists or to oral corticosteroids; (iii) in a child aged <2 years, three or more episodes of cough, wheezing and/or dyspnoea, including the index visit or (iv) previous lung function tests showing significant reversibility postbronchodilation (≥12% FEV1 or ≥25% Rrs at 4–8 Hz) or a positive provocation test (PC20 ≤8 mg/mL or provocation dose (to increase Rrs by 50% or more (PD50) ≤8 mg/mL), in keeping with the American Thoracic Society and European Respiratory Society criteria; (3) presented with an acute episode of cough, wheezing and/or dyspnoea; (4) had moderate-to-severe airway obstruction, defined as a PRAM score >3 at baseline; (5) had a good understanding of English or French and (6) were accompanied by parents or legal guardians.
Patients were excluded if they presented: (1) with another chronic respiratory condition (such as bronchopulmonary dysplasia or cystic fibrosis); (2) with a reasonable suspicion of bronchiolitis or foreign body aspiration; (3) a history of hypersensitivity to salbutamol, ipratropium bromide or oral prednisolone; (4) a relative or absolute contraindication to receiving oral corticosteroids such as recent exposure to varicella or live vaccine in a susceptible child or (5) with confirmed or suspected pregnancy status.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
-
Other specific population :
Children visiting emergency department with an asthma exacerbation.
-
Other specific population :
- Participants from Existing Studies
-
Number of Participants
- Number of Participants
- 975
- Number of Participants with Biological Samples
- 968
- Supplementary Information about selection criteria
-
From 975 enrolled patients:
Patients provided DNA samples: 906 samples
Patients provided Cotinine samples: 930 samples
Patients provided nasopharyngeal samples: 968 samples
Patients provided sputum samples: 11 samples
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
Index ED visit
|
Index ED visit (Baseline): demographics, treatment given, lung function assessment, determinants of response, PRAM scores, medications (current asthma, non-asthma and ... |
2011-02 | 2013-12 |
| 1 |
10-day follow up period
|
10-day follow up period: Patient functional status measured daily on the ‘Asthma flare-up Diary for young children©’, use of rescue and controller medications documented on a ... |
2011-02 | 2014-01 |
Classifications
- Socio-demographic and economic characteristics
- Lifestyle and behaviours
- Birth, pregnancy and reproductive health history
- Perception of health, quality of life, development and functional limitations
- Diseases
- Symptoms and signs
- Medication and supplements
- Non-pharmacological interventions
- Health and community care services utilization
- Death
- Physical measures and assessments
- Laboratory measures
- Cognition, personality and psychological measures and assessments
- Life events, life plans, beliefs and values
- Preschool, school and work life
- Social environment and relationships
- Physical environment
- Administrative information
Socio-demographic and economic characteristics
Lifestyle and behaviours
Perception of health, quality of life, development and functional limitations
Diseases
Symptoms and signs
Medication and supplements
Non-pharmacological interventions
Health and community care services utilization
Death
Physical measures and assessments
Laboratory measures
Physical environment
Administrative information