Asthma Exacerbation Clinical Trial
Official title:
In Vivo Prednisolone/Prednisone Pharmacokinetic Pilot Study in Children With Asthma Exacerbations
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.
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.
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