Pilot Study of How Children With Asthma Exacerbations Metabolize Prednisone
Recruitment status was Recruiting
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 department with an asthma exacerbation. The investigators hypothesis is that the pharmacokinetic profile in this population will be similar to healthy children and adults.
|Study Design:||Time Perspective: Prospective|
|Official Title:||In Vivo Prednisolone/Prednisone Pharmacokinetic Pilot Study in Children With Asthma Exacerbations|
- pharmacokinetic profile of prednisone and prednisolone [ Time Frame: over 8 hours post ingestion of medication ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||March 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260623
|Pediatric Emergency Department, Children's Hospital, London Health Sciences Centre||Recruiting|
|London, Ontario, Canada, N6A 5W9|
|Contact: Michael Rieder, MD, Ph.D, FRCPC (519) 685-8293 firstname.lastname@example.org|
|Contact: Shruti Mehrotra, MD, FRCPC (519) 685-8500 ext 14564 email@example.com|
|Sub-Investigator: Shruti Mehrotra, MD, FRCPC|
|Principal Investigator:||Michael Rieder, MD, Ph.D, FRCPC||Pediatric Emergency Dept, Children's Hospital, London Health Sciences Centre|