Pulmicort Respules on Relapse Rates After Treatment in the ED (Budesonide)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00584636
Recruitment Status : Withdrawn (study halted prematurely before enrollment of first patient)
First Posted : January 2, 2008
Last Update Posted : September 5, 2011
Information provided by:
Phoenix Children's Hospital

Brief Summary:
The purpose of this study is to see if the addition of budesonide to oral corticosteroids will result in a decrease in relapse rates compared to oral corticosteroids alone in children who are discharged from the ED after an asthma exacerbation. Secondly, that there will be an improvement in lung function, a decrease in beta-2 agonist use and an improvement in health-related quality of life compared to placebo.

Condition or disease Intervention/treatment Phase
Asthma Drug: pulmicort respules Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nebulized Budesonide After Discharge From a Pediatric Emergency Department in Preventing Asthma Relapse: A Randomized, Double-Blind, Placebo Controlled Trial.
Study Start Date : October 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: Pulmicort Respules
using pulmicort respules
Drug: pulmicort respules
pulmicort respules 0.5 mg twice a day for 28 days versus placebo
Other Name: Budesonide

Primary Outcome Measures :
  1. Number of unplanned ED or PCP visits for asthma in the 1 month following an ED visit for an asthma exacerbation. [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Use of rescue medications, hospitalizations and quality of life questionaires. [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patient is between the ages of 2 and 8

  • Has previously been diagnosed with asthma by any physician
  • Has presented to the ED with an asthma exacerbation judged by a physician that is believed would not required admission to the hospital

Exclusion Criteria:

  • Children less than 2 years (wheezing may be due to bronchiolitis)
  • Children who have been on oral or inhaled corticosteroid in the last week, are pregnant, or unavailable for follow-up
  • Pregnant
  • Has chronic lung diseases (i.e. cystic fibrosis)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00584636

United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Sponsors and Collaborators
Phoenix Children's Hospital
Principal Investigator: Robert B Bulloch, MD Phoenix Children's Hospital
Principal Investigator: Katherine Mandeville, MD Phoenix Children's Hospital

Responsible Party: Robert Bulloch, MD, Phoenix Children's Hospital Identifier: NCT00584636     History of Changes
Other Study ID Numbers: IRUSBUPR0034
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: September 5, 2011
Last Verified: September 2011

Keywords provided by Phoenix Children's Hospital:
emergency department

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists