Inhaled Corticosteroids After a Pediatric Emergency Visit for Asthma
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Purpose
Specific Aim:
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.
Hypotheses:
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
| Condition | Intervention |
|---|---|
|
Asthma |
Drug: Pulmicort or Flovent |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 150 |
| Study Start Date: | March 2006 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
|
Detailed Description:
Abstract.
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.
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Age 12 months through 18 years
History of asthma defined as 2 or more prior physician visits at which bronchodilators were prescribed
Persistent symptoms identified by an asthma control tool based on the NAEPP Guidelines and developed and validated by a multidisciplinary team of clinicians from CHOP Allergy, Pulmonary Medicine, General Pediatrics and Emergency Medicine. 20(Appendix 1)
Treated in ED for acute asthma with plan to discharge from the ED on oral prednisone
Exclusion Criteria:
Current hospitalization or admission to the extended day emergency care unit
History of pediatric intensive care admission for asthma
Current prescription for a controller medication such as ICS, leukotriene receptor antagonists, or cromolyn
Contraindications to the use of routine asthma medications including beta-agonists or systemic steroids
Co-morbid disease:
Chronic lung disease, for example cystic fibrosis
Congenital heart disease requiring surgery and/or medications
Sickle cell disease
Immunodeficiency syndromes
Previous enrollment in the study
-
Contacts and Locations More Information
No publications provided
| Responsible Party: | Esther Sampayo, CHOP |
| ClinicalTrials.gov Identifier: | NCT00294398 History of Changes |
| Other Study ID Numbers: | 2005-8-4458 |
| Study First Received: | February 20, 2006 |
| Last Updated: | November 13, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital of Philadelphia:
|
Asthma, Controller Medications |
Additional relevant MeSH terms:
|
Asthma Emergencies Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Disease Attributes Pathologic Processes Budesonide Fluticasone |
Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Dermatologic Agents Anti-Allergic Agents |
ClinicalTrials.gov processed this record on May 16, 2013