Pilot Study of How Children With Asthma Exacerbations Metabolize Prednisone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01260623
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : August 28, 2017
Information provided by (Responsible Party):
Lawson Health Research Institute

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 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 or disease Intervention/treatment
Asthma Exacerbation Drug: Prednisolone and prednisone

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 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
Observational Model: Other
Time Perspective: Prospective
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

Intervention Details:
    Drug: Prednisolone and prednisone
    oral, or intravenous prednisone, prednisolone, given the first time for asthma exacerbation

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01260623

Canada, Ontario
Pediatric Emergency Department, Children's Hospital, London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
Principal Investigator: Michael Rieder, MD, Ph.D, FRCPC Pediatric Emergency Dept, Children's Hospital, London Health Sciences Centre

Responsible Party: Lawson Health Research Institute Identifier: NCT01260623     History of Changes
Other Study ID Numbers: R-09-406
16380 ( Other Identifier: REB )
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017

Keywords provided by Lawson Health Research Institute:
asthma exacerbation
pharmacokinetic profile

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents