Pilot Study of How Children With Asthma Exacerbations Metabolize Prednisone

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01260623
First received: December 14, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Drug: Prednisolone and prednisone
    oral, or intravenous prednisone, prednisolone, given the first time for asthma exacerbation
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.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260623

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         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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 August 26, 2014