NCT00257933|CompletedPhase 4Results
Loading search results
Sponsor study identifier
interventional
152
1 country
1
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2006
Actual (reported)Study Completion
November 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2006
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 22, 2005
Actual (reported)November 24, 2005
Actual (reported)February 2006
Date type not reportedThis date has not been verified as actual or estimated.
November 2006
Actual (reported)November 2006
Actual (reported)August 11, 2010
Actual (reported)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
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
High dose prednisolone
Lower dose prednisolone alternating with placebo
4 mg/kg/day orally divided every 6 hours (maximum 30 mg per dose)
2 mg/kg/day orally divided q 12 (maximum 30mg/dose) alternating with placebo
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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
Joseph J Zorc, MD
Children's Hospital of Philadelphia
152 participants (actual enrollment reported by the registry).
First Submitted
November 22, 2005
First Posted
November 24, 2005
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Childhood Asthma Research and Education (CARE) Network Trial - Montelukast or Azithromycin for Reduction of Inhaled Corticosteroids in Childhood Asthma (MARS)
Contact the study team to confirm eligibility.
Primary Completion
November 2006
Actual (reported)Study Completion
November 2006
Actual (reported)Last Updated
December 31, 2010
Results First Posted
August 11, 2010
Record last verified: 2010-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: