Status:
COMPLETED
Pilot Study of How Children With Asthma Exacerbations Metabolize Prednisone
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Asthma Exacerbation
Eligibility:
All Genders
2-16 years
Brief Summary
The objective of the investigators pilot study is to assess the pharmacokinetic profile of two corticosteroid drugs, prednisone and prednisolone, in children who present to the pediatric emergency dep...
Detailed Description
The standard of practice in treating children with asthma exacerbations is to give corticosteroid drugs early in the course of the exacerbation. These drugs decrease symptoms, provide faster time to r...
Eligibility Criteria
Inclusion
- patients aged 2 to 16 years
- acute asthma exacerbation requiring an oral corticosteroid (either prednisone or prednisolone)
- any "reactive airways disease" treated like asthma
- \[Asthma is defined as at least 2 wheezing episodes and/or the patient has been treated with beta agonist and/or inhaled, oral or intravenous corticosteroids for the recurrent episodes of wheezing in the past\] \[Acute asthma exacerbation is defined as wheezing episode with any of the following symptoms: tachypnea, dyspnea, use of accessory muscles, or an increased need for short acting beta agonist prior to presentation to PED\]
Exclusion
- any systemic corticosteroid use within 1 week of presentation to PED
- use of any other corticosteroid apart from oral prednisone or prednisolone for the current acute asthma exacerbation
- bronchiolitis
- underlying chronic medical condition other than asthma (ie: cystic fibrosis, nephrotic syndrome, epilepsy, etc)
- liver impairment (including elevated transaminases)
- renal impairment
- primary or secondary immunodeficiences
- concomitant immunosuppressive medication use
- IVIG use within 4 weeks
- need for assisted ventilation
Key Trial Info
Start Date :
September 9 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01260623
Start Date
September 9 2009
End Date
May 31 2013
Last Update
August 28 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pediatric Emergency Department, Children's Hospital, London Health Sciences Centre
London, Ontario, Canada, N6A 5W9