Overview

Pilot Study of How Children With Asthma Exacerbations Metabolize Prednisone

Status:
Completed
Trial end date:
2013-05-31
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lawson Health Research Institute
Treatments:
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone
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