Phase 4
Completed N=152
Oral Prednisolone Dosing in Children Hospitalized With Asthma
Source: ClinicalTrials.gov NCT00257933 ↗Enrolled (actual)
152
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcomePrimary: 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 — 35; 33 Hours
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
35; 33 | — |
| SECONDARY Time Measured From the Writing of the Admission Order Until the Writing of the Discharge Order |
— | — |
| SECONDARY Time Spent in Each Severity Level of the Asthma Care Pathway |
— | — |
| SECONDARY The Rate and Degree of Change in Forced Expiratory Volume (FEV1) and Peak Expiratory Flow (PEF) Between Treatment Groups |
— | — |
| SECONDARY Differences in Clinical Asthma Symptom Scores During Hospitalization Between Treatment Groups |
— | — |
| SECONDARY Rate of Relapse Between Treatment Groups |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00257933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.