Pulmicort Respules on Relapse Rates After Treatment in the ED
Pulmicort Respules on Relapse Rates After Treatment in the ED
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.
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)