Inhaled Corticosteroids After a Pediatric Emergency Visit for Asthma
To determine whether a prescription for ICS added to standard ED discharge therapy for young children with persistent asthma symptoms increases ICS use and improves symptoms and quality of life over the months following the ED visit.
In a cohort of pediatric patients with persistent asthma discharged from the ED after an acute asthma exacerbation, a prescription for ICS will:
- Improve usage of ICS as measured by refill of a prescription within the first 2 months after the ED visit
- Improve symptom severity at two weeks after an ED visit as measured by days of cough, wheeze, missed school, daycare or work
- Improve patient and caregiver asthma-related quality of life during the 2 months following an ED visit measured by asthma HRQL
- Improve asthma control at 2 months as measured by a validated asthma instrument
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Inhaled Corticosteroids After a Pediatric Emergency Visit for Asthma|
- Continued prescription for ICS by PCP [ Time Frame: 2 mo ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 2mo ] [ Designated as safety issue: No ]
- Symptom Severity [ Time Frame: 2wk, 2mo ] [ Designated as safety issue: No ]
- Asthma control [ Time Frame: 2mo ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Standard asthma care with or without prescription for controller medications
Drug: Pulmicort or Flovent
Patient will be randomized to receive standard asthma care with or without initiation of inhaled corticosteroid prescription
Background: Asthma prevalence, emergency visits, and hospitalizations have increased substantially, especially among young children and urban populations. Although inhaled corticosteroids (ICS) are the mainstay of treatment for persistent asthma, studies have demonstrated a low rate of ICS usage and primary care provider follow-up within a month of an Emergency Department (ED) visit. Furthermore, ICS usage and adherence with National Asthma Education and Prevention Program (NAEPP) recommendations is low even for children that follow-up with their primary care physician (PCP). In addition, other studies have demonstrated frequent symptoms, activity restriction, and missed school or work during the weeks following an ED visit. Prescribing ICS at ED discharge occurs uncommonly in the United States based on surveys and reviews of current practice. Adult studies have been inconclusive and the role of ICS after a pediatric emergency visit for asthma has not been studied. This study will assess the short-term outcomes of prescribing ICS to young children with persistent asthma symptoms after an emergency visit for asthma.
Objective: To determine whether a prescription for ICS added to standard asthma ED discharge therapy to young children with persistent asthma increases adherence to NAEPP guidelines for ICS usage at 2 months follow up and improves short-term symptoms and quality of life for patient and caregiver.
Methods: Randomized control trial of children 1- 8yo of age with persistent asthma being discharged after an emergency visit for asthma. Subjects will be randomized to receive standard therapy of oral corticosteroid, albuterol, and education versus standard care plus a prescription for budesonide once daily. A questionnaire will be administered at baseline, with follow-up telephone interviews conducted at 2 weeks and 2 months. Pharmacy verification of refill of a second prescription of ICS will be the primary outcome. Asthma symptoms and quality of life will be assessed as secondary outcomes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294398
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Esther M Sampayo, MD||CHOP|