Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257933
Status:
COMPLETED
Last Update Posted:
2010-12-31
First Post:
2005-11-22
Brief Title:
Oral Prednisolone Dosing in Children Hospitalized With Asthma
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Oral Prednisolone Dosing in Children Hospitalized With Asthma
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study hopes to determine the appropriate oral steroid dose for treating children hospitalized with asthma exacerbations Practice guidelines from different countries recommend a wide range of doses and the doses used in actual practice vary widely There is no data on what is the most appropriate dose of prednisone or equivalent in this situation We will be looking at the dose recommended by the National Asthma Education and Prevention Program guidelines which are published by the National Heart Lung and Blood Institute as compared with a lower dose which is commonly used in practice We hypothesize that the lower dose will be no worse than the higher dose as determined primarily by duration of hospitalization
Detailed Description:
Practice guidelines for the management of asthma in children universally recommend systemic corticosteroids for the treatment of moderate to severe asthma exacerbations However these guidelines vary widely with respect to dose frequency method of delivery and duration of therapy In actual practice there is also considerable variation among clinicians in terms of corticosteroid dosing in children hospitalized with asthma exacerbations At the Childrens Hospital of Philadelphia CHOP the current standard is to use an initial dose of 40 mgkgday 10 mgkg every 6 hours to a maximum of 30 mgdose although many other pediatric hospitals use a 20 mgkgday dose 10 mgkg every 12 hours to a maximum of 30 mgdose Systematic reviews of the literature have called for a clinical trial to evaluate the effect of different doses of corticosteroids in treating pediatric asthma patients hospitalized with exacerbations
This study will use a randomized double-blind controlled trial design in order to compare the efficacy of two different steroid doses in resolving acute exacerbations of asthma in hospitalized children Children being hospitalized for asthma exacerbations from the CHOP emergency department ED will be eligible for study enrollment Those that meet enrollment criteria will be randomized to receive prednisolone either in the higher dose 10 mgkg max 30 mg every 6 hours or the lower dose 10 mgkg max 30 mg every 12 hours and placebo doses at 6 hour intervals in between for the first 48 hours of hospitalization Once 48 hours has past all patients still hospitalized will receive 10 mgkg max 30 mg every 12 hours for the duration of hospitalization Approximately 156 patients with 78 in each arm of the study will be enrolled This study should be completed in six to eight months A non-inferiority study design will be used The primary outcome will be duration of hospitalization as determined by duration of time elapsed from first dose of prednisolone administered in the emergency department ED until the discharge dose of albuterol is administered Secondary outcomes will include time elapsed from the time the admission order is written until the discharge order is written time spent in each severity level of the asthma care pathway degree and rate of improvement in forced expiratory volume in one second FEV1 improvement in peak expiratory flows PEF improvement in asthma symptom scores and rate of relapse after discharge
This study will use a randomized double-blind controlled trial design in order to compare the efficacy of two different steroid doses in resolving acute exacerbations of asthma in hospitalized children Children being hospitalized for asthma exacerbations from the CHOP emergency department ED will be eligible for study enrollment Those that meet enrollment criteria will be randomized to receive prednisolone either in the higher dose 10 mgkg max 30 mg every 6 hours or the lower dose 10 mgkg max 30 mg every 12 hours and placebo doses at 6 hour intervals in between for the first 48 hours of hospitalization Once 48 hours has past all patients still hospitalized will receive 10 mgkg max 30 mg every 12 hours for the duration of hospitalization Approximately 156 patients with 78 in each arm of the study will be enrolled This study should be completed in six to eight months A non-inferiority study design will be used The primary outcome will be duration of hospitalization as determined by duration of time elapsed from first dose of prednisolone administered in the emergency department ED until the discharge dose of albuterol is administered Secondary outcomes will include time elapsed from the time the admission order is written until the discharge order is written time spent in each severity level of the asthma care pathway degree and rate of improvement in forced expiratory volume in one second FEV1 improvement in peak expiratory flows PEF improvement in asthma symptom scores and rate of relapse after discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None