Pilot Study of How Children With Asthma Exacerbations Metabolize Prednisone

NCT01260623 | Completed

• 2 other identifiers: R-09-40616380
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma Exacerbation

Keywords

asthma; pharmacokinetics; prednisone; prednisolone; asthma exacerbation; pharmacokinetic profile

Outcome Measures

Primary Outcomes (1)

• pharmacokinetic profile of prednisone and prednisolone

  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.

  over 8 hours post ingestion of medication

Interventions

Prednisolone and prednisone DRUG

oral, or intravenous prednisone, prednisolone, given the first time for asthma exacerbation

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• patients aged 2 to 16 years
• acute asthma exacerbation requiring an oral corticosteroid (either prednisone or prednisolone)
• any "reactive airways disease" treated like asthma
• \[Asthma is defined as at least 2 wheezing episodes and/or the patient has been treated with beta agonist and/or inhaled, oral or intravenous corticosteroids for the recurrent episodes of wheezing in the past\] \[Acute asthma exacerbation is defined as wheezing episode with any of the following symptoms: tachypnea, dyspnea, use of accessory muscles, or an increased need for short acting beta agonist prior to presentation to PED\]

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Pediatric Emergency Department, Children's Hospital, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

Prednisolone; Prednisone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols

Study Officials

• Michael Rieder, MD, Ph.D, FRCPC

  Pediatric Emergency Dept, Children's Hospital, London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 15, 2010
• Study Start: September 9, 2009
• Primary Completion: May 31, 2013
• Study Completion: May 31, 2013
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

CA (1)