Pilot Study of How Children With Asthma Exacerbations Metabolize Prednisone
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Asthma Exacerbation |
Drug: Prednisolone and prednisone |
| Study Type: | Observational |
| 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.
| Estimated Enrollment: | 20 |
| 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) |
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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.
Eligibility| Ages Eligible for Study: | 2 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
children between the ages of 2 and 16 years who present to the tertiary care pediatric emergency department in London, Ontario with an asthma exacerbation
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations| Canada, Ontario | |
| 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 mrieder@uwo.ca | |
| Contact: Shruti Mehrotra, MD, FRCPC (519) 685-8500 ext 14564 shruti.mehrotra@londonhospitals.ca | |
| Sub-Investigator: Shruti Mehrotra, MD, FRCPC | |
| Principal Investigator: | Michael Rieder, MD, Ph.D, FRCPC | Pediatric Emergency Dept, Children's Hospital, London Health Sciences Centre |
More Information
No publications provided
| Responsible Party: | Dr. Michael Rieder, Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01260623 History of Changes |
| Other Study ID Numbers: | R-09-406, 16380 |
| Study First Received: | December 14, 2010 |
| Last Updated: | December 14, 2010 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Lawson Health Research Institute:
|
asthma pharmacokinetics prednisone |
prednisolone asthma exacerbation pharmacokinetic profile |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Methylprednisolone acetate Prednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisone |
Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013