Oral Prednisolone Dosing in Children Hospitalized With Asthma

Asthma Clinical Trial

Official title:

Oral Prednisolone Dosing in Children Hospitalized With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257933
• Other study ID #: 2005-9-4377
• Status: Completed
• Phase: Phase 4
• First received: November 22, 2005
• Last updated: December 23, 2010
• Start date: February 2006
• Est. completion date: November 2006

Study information

• Verified date: December 2010
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Prednisolone high dose
4 mg/kg/day orally divided every 6 hours (maximum 30 mg per dose)
• Prednisolone lower dose
2 mg/kg/day orally divided q 12 (maximum 30mg/dose) alternating with placebo

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered		Median time from loading dose to home dose of albuterol	No
Secondary	Time Measured From the Writing of the Admission Order Until the Writing of the Discharge Order		Mean time from writing admit order until discharge order	No
Secondary	Time Spent in Each Severity Level of the Asthma Care Pathway		Time spent in each severity level of pathway	No
Secondary	The Rate and Degree of Change in Forced Expiratory Volume (FEV1) and Peak Expiratory Flow (PEF) Between Treatment Groups		Every 4 hours during hospitalization	No
Secondary	Differences in Clinical Asthma Symptom Scores During Hospitalization Between Treatment Groups		Every 4 hours during hospitalization	No
Secondary	Rate of Relapse Between Treatment Groups		2 weeks after hospitalization	No