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Oral Prednisolone Dosing in Children Hospitalized With Asthma

NCT00257933 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2010-12-31

Study results available
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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.

Conditions

Interventions

DRUG

Prednisolone high dose

4 mg/kg/day orally divided every 6 hours (maximum 30 mg per dose)

DRUG

Prednisolone lower dose

2 mg/kg/day orally divided q 12 (maximum 30mg/dose) alternating with placebo

Sponsors & Collaborators

Principal Investigators

  • Joseph J Zorc, MD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00257933 on ClinicalTrials.gov