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

This study has been withdrawn prior to enrollment.
(study halted prematurely before enrollment of first patient)
Sponsor:
Information provided by:
Phoenix Children's Hospital
ClinicalTrials.gov Identifier:
NCT00584636
First received: December 20, 2007
Last updated: September 2, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Asthma
Drug: pulmicort respules
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Phoenix Children's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of rescue medications, hospitalizations and quality of life questionaires. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT00584636

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

No publications provided

Responsible Party: Robert Bulloch, MD, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT00584636     History of Changes
Other Study ID Numbers: IRUSBUPR0034
Study First Received: December 20, 2007
Last Updated: September 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Phoenix Children's Hospital:
child
emergency department

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

ClinicalTrials.gov processed this record on November 24, 2014