Inhaled Corticosteroids After a Pediatric Emergency Visit for Asthma

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00294398
First received: February 20, 2006
Last updated: November 13, 2009
Last verified: November 2009
  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:

  1. Improve usage of ICS as measured by refill of a prescription within the first 2 months after the ED visit
  2. Improve symptom severity at two weeks after an ED visit as measured by days of cough, wheeze, missed school, daycare or work
  3. Improve patient and caregiver asthma-related quality of life during the 2 months following an ED visit measured by asthma HRQL
  4. 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

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Continued prescription for ICS by PCP [ Time Frame: 2 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00294398

Locations
United States, Pennsylvania
CHOP
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Esther M Sampayo, MD CHOP
  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
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014