Oral Prednisolone Dosing in Children Hospitalized With Asthma

NCT00257933 | Completed Phase 4 Results

• 1 other identifier: 2005-9-4377
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Corticosteroids; Treatment; Pediatric

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• Time Spent in Each Severity Level of the Asthma Care Pathway

  Time spent in each severity level of pathway

• The Rate and Degree of Change in Forced Expiratory Volume (FEV1) and Peak Expiratory Flow (PEF) Between Treatment Groups

  Every 4 hours during hospitalization

• Differences in Clinical Asthma Symptom Scores During Hospitalization Between Treatment Groups

  Every 4 hours during hospitalization

• Rate of Relapse Between Treatment Groups

  2 weeks after hospitalization

Study Arms (2)

1

ACTIVE COMPARATOR

High dose prednisolone

Drug: Prednisolone high dose

2

EXPERIMENTAL

Lower dose prednisolone alternating with placebo

Drug: Prednisolone lower dose

Interventions

Prednisolone high dose DRUG

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

Also known as: High Dose Prednisolone, Oral steriod, corticosteriods, asthma exacerbations

1

Prednisolone lower dose DRUG

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

Also known as: Low dose Prednisolone, Oral prednisolone, Oral steriod, corticosteriods, asthma exacerbations

2

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Limited ability to measure pulmonary function in hospitalized children with asthma did not allow measurement of this outcome. Some protocol violations occurred Single center study

Results Point of Contact

• Title: Joseph Zorc, MD
• Organization: The Children's Hospital of Philadelphia

zorc@email.chop.edu

215-590-1944

Study Officials

• Joseph J Zorc, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 24, 2005
• Study Start: February 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: December 31, 2010
• Results First Posted: August 11, 2010

Record last verified: 2010-12

Locations

US (1)