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Inhaled Corticosteroids After a Pediatric Emergency Visit for Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00294398
First received: February 20, 2006
Last updated: April 23, 2015
Last verified: April 2015
  Purpose

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

Condition Intervention
Asthma
Other: ICS Prescription + Standard Asthma ED Discharge Therapy
Other: Standard Asthma ED Discharge Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel 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:
  • Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Verification of a filled prescription for an ICS was completed 2 months after emergency department (ED) visit via telephone call to the pharmacy. Individual informed consent forms were faxed to the pharmacy to obtain verification that a prescription was filled. The number of subjects who filled a prescription for an ICS after the ED visit was compared between the two groups.


Secondary Outcome Measures:
  • Asthma-related Quality of Life [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Bukstein health-related quality of life instrument is an an 8-item questionnaire for measuring health-related quality of life in pediatric asthma. The daytime and nighttime symptom scales for each contain 2 items and the functional limitations scale 4 items. Prior validation studies confirm each scale's ability to detect changes at both low and high levels of functioning. The scale is scored from 0 to 100, with higher scores indicating better quality of life and lower scores translate to poorer health-related quality of life.


Enrollment: 152
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
Standard Asthma ED Discharge Therapy
Standard asthma therapy including oral corticosteroids, albuterol, education and discharge instructions.
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.
Other Name: Control
Experimental: 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

Other: 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

Other Names:
  • Budesonide
  • Fluticasone propionate
  • Pulmicort
  • Flovent

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   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00294398     History of Changes
Other Study ID Numbers: 2005-8-4458 
Study First Received: February 20, 2006
Results First Received: May 20, 2013
Last Updated: April 23, 2015
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
Fluticasone
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 26, 2016