Oral Prednisolone Dosing in Children Hospitalized With Asthma

NCT ID: NCT00257933

Last Updated: 2010-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2006-11-30

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 Children's Hospital of Philadelphia (CHOP) the current standard is to use an initial dose of 4.0 mg/kg/day (1.0 mg/kg every 6 hours to a maximum of 30 mg/dose) although many other pediatric hospitals use a 2.0 mg/kg/day dose (1.0 mg/kg every 12 hours to a maximum of 30 mg/dose). 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 (1.0 mg/kg (max 30 mg) every 6 hours), or the lower dose (1.0 mg/kg (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 1.0 mg/kg (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.

Conditions

Asthma

Keywords

Corticosteroids; Treatment; Pediatric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

High dose prednisolone

Group Type: ACTIVE_COMPARATOR

Prednisolone high dose

Intervention Type: DRUG

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

2

Lower dose prednisolone alternating with placebo

Group Type: EXPERIMENTAL

Prednisolone lower dose

Intervention Type: DRUG

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

Interventions

Prednisolone high dose

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

Intervention Type: DRUG

Prednisolone lower dose

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

Intervention Type: DRUG

Other Intervention Names

High Dose Prednisolone; Oral steriod; corticosteriods; asthma exacerbations; Low dose Prednisolone; Oral prednisolone; Oral steriod; corticosteriods; asthma exacerbations

Eligibility Criteria

Inclusion Criteria

• Physician-diagnosed asthma with at least two previous visits to ED or primary care provider for asthma care
• Clinical decision by ED attending physician to admit to Acute Care Unit (ACU) after standardized initial ED treatment

Exclusion Criteria

• Clinical decision to begin continuous intravenous beta-agonist infusion
• Clinical decision to begin intravenous methylprednisolone therapy
• Clinical decision to admit to the Pediatric Intensive Care Unit
• Other concurrent disease such as sickle cell disease, cystic fibrosis, or cardiac disease
• Any contraindication to corticosteroid administration
• Any systemic corticosteroid treatment within two weeks of presenting to the ED
• Potential subjects will be excluded if informed consent is not obtained

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

The Children's Hospital of Philadelphia

Principal Investigators

Joseph J Zorc, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

2005-9-4377

Identifier Type: -

Identifier Source: org_study_id