Inhaled Corticosteroids After a Pediatric Emergency Visit for Asthma

NCT ID: NCT00294398

Last Updated: 2015-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-11-30

Brief Summary

Specific Aim:

To determine whether a prescription for Inhaled Corticosteroids (ICS) added to standard Emergency Department (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 Health Related Quality of Life (HRQL)

4. Improve asthma control at 2 months as measured by a validated asthma instrument

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard Asthma ED Discharge Therapy

Standard asthma therapy including oral corticosteroids, albuterol, education and discharge instructions.

Group Type: OTHER

Standard Asthma ED Discharge Therapy

Intervention Type: OTHER

Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.

ICS Prescription + Standard Asthma ED Discharge Therapy

Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:

1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily

Group Type: EXPERIMENTAL

ICS Prescription + Standard Asthma ED Discharge Therapy

Intervention Type: OTHER

Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:

1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily

Interventions

ICS Prescription + Standard Asthma ED Discharge Therapy

Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:

1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily

Intervention Type: OTHER

Standard Asthma ED Discharge Therapy

Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.

Intervention Type: OTHER

Other Intervention Names

Budesonide; Fluticasone propionate; Pulmicort; Flovent; Control

Eligibility Criteria

Inclusion Criteria

1. Age 12 months through 18 years

2. History of asthma defined as 2 or more prior physician visits at which bronchodilators were prescribed

3. 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.

4. Treated in ED for acute asthma with plan to discharge from the ED on oral prednisone

5. Have a Primary Care Physician (PCP)

Exclusion Criteria

1. Current hospitalization or admission to the extended day emergency care unit

2. History of pediatric intensive care admission for asthma

3. Current prescription for a controller medication such as inhaled corticosteroids (ICS), leukotriene receptor antagonists, or cromolyn

4. Contraindications to the use of routine asthma medications including beta-agonists or systemic steroids

5. Co-morbid disease: Chronic lung disease, for example cystic fibrosis; Congenital heart disease requiring surgery and/or medications; Sickle cell disease; Immunodeficiency syndromes

6. Previous enrollment in the study

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esther M Sampayo, MD

Role: PRINCIPAL_INVESTIGATOR

CHOP

Locations

CHOP

Philadelphia, Pennsylvania, United States

Countries

United States

References

Bukstein DA, McGrath MM, Buchner DA, Landgraf J, Goss TF. Evaluation of a short form for measuring health-related quality of life among pediatric asthma patients. J Allergy Clin Immunol. 2000 Feb;105(2 Pt 1):245-51. doi: 10.1016/s0091-6749(00)90072-1.

Reference Type: BACKGROUND

PMID: 10669843 (View on PubMed)

Zorc JJ, Pawlowski NA, Allen JL, Bryant-Stephens T, Winston M, Angsuco C, Shea JA. Development and validation of an instrument to measure asthma symptom control in children. J Asthma. 2006 Dec;43(10):753-8. doi: 10.1080/02770900601031615.

Reference Type: BACKGROUND

PMID: 17169827 (View on PubMed)

Other Identifiers

2005-8-4458

Identifier Type: -

Identifier Source: org_study_id