Oral Prednisolone Dosing in Children Hospitalized With Asthma

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00257933
First received: November 22, 2005
Last updated: December 23, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Prednisolone high dose
Drug: Prednisolone lower dose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Prednisolone Dosing in Children Hospitalized With Asthma

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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 [ Time Frame: Median time from loading dose to home dose of albuterol ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time Measured From the Writing of the Admission Order Until the Writing of the Discharge Order [ Time Frame: Mean time from writing admit order until discharge order ] [ Designated as safety issue: No ]
  • Time Spent in Each Severity Level of the Asthma Care Pathway [ Time Frame: Time spent in each severity level of pathway ] [ Designated as safety issue: No ]
  • The Rate and Degree of Change in Forced Expiratory Volume (FEV1) and Peak Expiratory Flow (PEF) Between Treatment Groups [ Time Frame: Every 4 hours during hospitalization ] [ Designated as safety issue: No ]
  • Differences in Clinical Asthma Symptom Scores During Hospitalization Between Treatment Groups [ Time Frame: Every 4 hours during hospitalization ] [ Designated as safety issue: No ]
  • Rate of Relapse Between Treatment Groups [ Time Frame: 2 weeks after hospitalization ] [ Designated as safety issue: No ]

Enrollment: 152
Study Start Date: February 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
High dose prednisolone
Drug: Prednisolone high dose
4 mg/kg/day orally divided every 6 hours (maximum 30 mg per dose)
Other Names:
  • High Dose Prednisolone
  • Oral steriod
  • corticosteriods
  • asthma exacerbations
Experimental: 2
Lower dose prednisolone alternating with placebo
Drug: Prednisolone lower dose
2 mg/kg/day orally divided q 12 (maximum 30mg/dose) alternating with placebo
Other Names:
  • Low dose Prednisolone
  • Oral prednisolone
  • Oral steriod
  • corticosteriods
  • asthma exacerbations

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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257933

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Joseph J Zorc, MD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Joseph J. Zorc, M.D., The Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00257933     History of Changes
Other Study ID Numbers: 2005-9-4377
Study First Received: November 22, 2005
Results First Received: July 14, 2010
Last Updated: December 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
Corticosteroids
Treatment
Pediatric

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 28, 2014