Pilot Study of How Children With Asthma Exacerbations Metabolize Prednisone
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|ClinicalTrials.gov Identifier: NCT01260623|
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : August 28, 2017
|Condition or disease||Intervention/treatment|
|Asthma Exacerbation||Drug: Prednisolone and prednisone|
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 recovery and improve of quality of life. However, there is 100% variability in a child's response to corticosteroids at a standard dose which is based on primarily on adult studies. The pharmacokinetic analysis or the process by which a drug is metabolized by the body is the first step to determine the proper dose.
Patients between the ages of 2 and 16 years with asthma exacerbations will be recruited from the pediatric emergency department. After the patients get the drugs, blood samples will be drawn over 8 hours to get the following parameters: maximum concentration reached in the body, the time for the drug to be eliminated from the body, how long the drug stays in the body, how much of the drug is found in the urine after it is given, and concentration of metabolites or breakdown products in urine and blood. These are the parameters needed to make the pharmacokinetic profile and is the first step towards appropriate dosing of these two medications for asthma exacerbations in children.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||In Vivo Prednisolone/Prednisone Pharmacokinetic Pilot Study in Children With Asthma Exacerbations|
|Actual Study Start Date :||September 9, 2009|
|Actual Primary Completion Date :||May 31, 2013|
|Actual Study Completion Date :||May 31, 2013|
Drug: Prednisolone and prednisone
- pharmacokinetic profile of prednisone and prednisolone [ Time Frame: over 8 hours post ingestion of medication ]The children will receive prednisone or prednisolone by mouth at current standard dose of 1mg/kg. Blood samples will be drawn from the catheter at baseline (0 hours), 1, 2, 4, 6, and 8 hours post ingestion of the medication. All samples will be analyzed for prednisone and prednisolone concentrations, and breakdown product concentrations. Urine samples will be collected prior to discharge for analysis of fractional excretion of prednisone, prednisolone, and the metabolites.
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): NCT01260623
|Pediatric Emergency Department, Children's Hospital, London Health Sciences Centre|
|London, Ontario, Canada, N6A 5W9|
|Principal Investigator:||Michael Rieder, MD, Ph.D, FRCPC||Pediatric Emergency Dept, Children's Hospital, London Health Sciences Centre|