NCT00294398

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. 1.Improve usage of ICS as measured by refill of a prescription within the first 2 months after the ED visit
  2. 2.Improve symptom severity at two weeks after an ED visit as measured by days of cough, wheeze, missed school, daycare or work
  3. 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. 4.Improve asthma control at 2 months as measured by a validated asthma instrument

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

April 24, 2015

Completed
Last Updated

May 13, 2015

Status Verified

April 1, 2015

Enrollment Period

3.7 years

First QC Date

February 20, 2006

Results QC Date

May 20, 2013

Last Update Submit

April 23, 2015

Conditions

Asthma

Keywords

Asthma, Controller Medications

Outcome Measures

Primary Outcomes (1)

  • Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician)

    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.

    2 months

Secondary Outcomes (1)

  • Asthma-related Quality of Life

    2 months

Study Arms (2)

Standard Asthma ED Discharge Therapy

OTHER

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

Other: Standard Asthma ED Discharge Therapy

ICS Prescription + Standard Asthma ED Discharge Therapy

EXPERIMENTAL

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

Interventions

ICS Prescription + Standard Asthma ED Discharge TherapyOTHER

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

Also known as: Budesonide, Fluticasone propionate, Pulmicort, Flovent
ICS Prescription + Standard Asthma ED Discharge Therapy
Standard Asthma ED Discharge TherapyOTHER

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.

Also known as: Control
Standard Asthma ED Discharge Therapy

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.
  • Treated in ED for acute asthma with plan to discharge from the ED on oral prednisone
  • Have a Primary Care Physician (PCP)

You may not qualify if:

  • 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 inhaled corticosteroids (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHOP

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

    PMID: 10669843BACKGROUND

  • 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.

    PMID: 17169827BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

BudesonideFluticasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAndrostadienesAndrostenesAndrostanes

Results Point of Contact

Title
Esther Sampayo MD MPH
Organization
CHOP
sampayo@email.chop.edu
215-590-1944

Study Officials

  • Esther M Sampayo, MD

    CHOP

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2006

First Posted

February 22, 2006

Study Start

March 1, 2006

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

May 13, 2015

Results First Posted

April 24, 2015

Record last verified: 2015-04

Locations

US(1)