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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This study has been withdrawn prior to enrollment.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

December 20, 2007
September 2, 2011
October 2007
March 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00584636 on ClinicalTrials.gov Archive Site
Use of rescue medications, hospitalizations and quality of life questionaires. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pulmicort Respules on Relapse Rates After Treatment in the ED
Nebulized Budesonide After Discharge From a Pediatric Emergency Department in Preventing Asthma Relapse: A Randomized, Double-Blind, Placebo Controlled Trial.

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.

Children between the ages of 2 and 8 years inclusive who have a history of asthma are eligible for enrollment if they present to the pediatric emergency department with an asthma exacerbation that is believed would not require admission to the hospital. All eligible children will be enrolled whenever there are study personnel available after obtaining informed written consent. Children less than 2 years of age will not be enrolled as their wheezing may be due to bronchiolitis. Children will also be excluded if they have been on an oral or inhaled corticosteroid in the last week, have a history of a chronic lung disease (e.g. cystic fibrosis), non-corrected congenital heart disease, are pregnant, or unavailable for follow-up.

Initial asthma severity will be based on PEFR's or clinical asthma scores (table 1). If the child is able to reliably provide a peak flow in the emergency department this value will be recorded and calculated as a percentage of their predicted based on standardized height and weight charts. All peak flows will be performed by licensed respiratory therapists or trained registered nurses. If a childs effort during the performance of the peak flows is considered poor by the respiratory therapist then only the asthma score will be utilized. If a child can perform the peak flows adequately they will be sent home with the peak flow meter. All children will be assigned clinical asthma scores regardless of whether peak flows are obtained. With this asthma scale a score of less than 7 is considered mild, 8 to 11 moderate and a score of 12 to 15 severe. This asthma score has been shown to have good interobserver reliability with a Pearson correlation statistic of 0.92.

Children will be treated based on normal practice patterns for our ED and the decision to discharge a patient will be at the attending physician's discretion. All children will receive 2 mg/kg of methylprednisolone up to a maximum dose of 60 mg orally within the first 60 minutes of treatment or 0.6mg/kg of oral dexamethasone (max 15mg) given in the Emergency room. When discharged home all children will be given a prescription for 4 days of methylprednisolone in a dose of 1 mg/kg given once daily Patients will be assigned in a double blind fashion to budesonide nebules or placebo. A computer generated table of random numbers will be used to assign children to treatment group. Groups will be randomized in blocks of 10. A locked area in the ED will contain numbered plastic bags each containing either budesonide nebules or identical appearing and tasting placebo nebules. Study personnel and patients will be blinded to treatment allocation for the entire length of the trial. Patients will be given instructions on the use and dosage (based on weight) of the study medications.

All patients will be contacted by telephone at 7 days. They will be followed for 28 days or until they relapse, whichever comes first. Relapse will be defined as any unscheduled physician visit for worsening asthma symptoms. At the time of telephone follow-up patients will be asked about symptoms as well as about compliance with their study medications (see data collection sheet). At the return visit on day 28 they will be asked to bring their medication with them to determine compliance. At that time they will also have peak flows obtained and a repeat assessment of the quality of life scale.

In order to measure health-related quality of life, the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) will be completed by a research assistant upon enrollment, via telephone follow-up 7 days after the emergency department visit, and at the 28 day follow-up visit. The ITG-CASF has previously been validated in children with chronic asthma. Gorelick et al have shown it to be a valid and responsive measure of health-related quality of life in children as young as 2 years of age treated in an emergency department for acute asthma. The 8-item ITG Child Asthma Short Form measures the following three concepts: Daytime Symptoms, Nighttime Symptoms, and Functional Limitations. In addition to the standard 8-item ITG Child Asthma Short Form, they identified two additional items from the long form to assess whether inhaler use interfered with the child's life and whether adjustments were made to family life because of the child's asthma.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
Drug: pulmicort respules
pulmicort respules 0.5 mg twice a day for 28 days versus placebo
Other Name: Budesonide
Experimental: Pulmicort Respules
using pulmicort respules
Intervention: Drug: pulmicort respules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2009
March 2009   (final data collection date for primary outcome measure)

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)
Both
2 Years to 8 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00584636
IRUSBUPR0034
Yes
Robert Bulloch, MD, Phoenix Children's Hospital
Phoenix Children's Hospital
Not Provided
Principal Investigator: Robert B Bulloch, MD Phoenix Children's Hospital
Principal Investigator: Katherine Mandeville, MD Phoenix Children's Hospital
Phoenix Children's Hospital
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP