Inhaled Steroids at Discharge After Emergency Department Visits for Children With Uncontrolled Asthma

NCT01881412 | Terminated Results DMC

• 1 other identifier: ACP-231928-N
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Many children have asthma and this causes problems with their health. A lot of children with uncontrolled asthma use emergency departments for asthma care, and so this is an ideal place for an intervention for these children. One intervention is prescribing inhaled steroids to children with uncontrolled asthma, but currently this is rarely done in the emergency department. Inhaled steroids have been shown to be good at making children better long-term when they have uncontrolled asthma. This study identifies children in the emergency department with uncontrolled asthma using a tool called the Pediatric Asthma Control and Communication Instrument (PACCI). If children meet criteria for uncontrolled asthma they will be randomly assigned to either: 1) routine asthma care which includes close follow up with their doctor or 2) prescribing of an inhaled corticosteroid from the emergency department. The investigators hypothesize that children who are prescribed inhaled steroids for uncontrolled asthma from the emergency department will have better 6 month asthma control than children who receive routine asthma care.

Conditions

Asthma

Keywords

Asthma; Children; Inhaled Corticosteroids; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form

  The Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) has been validated in the ED setting for children 2 to 17 years old, is reliable (Cronbach's α =0.70), and can be administered by telephone. Each item is rated on a 5-point scale. Each response is scaled as a percentage of the maximum response, and the total score is the maximum percentage based on the number of questions answered. The scores range from 0 (minimum) - 100 (maximum), with higher scores reflecting better quality of life. The change in ITG-CASF scores for children with improved overall clinical status are 10 points higher than when children have not improved.

  6 months

Secondary Outcomes (5)

• ED Visits for Asthma

  6 months

• Primary Care Visits for Well Checks

  6 months

• Hospitalizations for Asthma

  6 months

• Unscheduled Primary Care Visits

  6 months

• Oral Steroid Courses

  6 months

Study Arms (2)

Inhaled corticosteroid (fluticasone)

EXPERIMENTAL

Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.

Drug: fluticasone; Other: Standard Asthma Discharge Instructions

Routine Asthma Care

PLACEBO COMPARATOR

Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)

Other: Standard Asthma Discharge Instructions

Interventions

fluticasone DRUG

During discharge, the study MD/nurse informs the family that the child has been randomized to the inhaled corticosteroid (ICS) group, and will be prescribed fluticasone to help control the asthma. The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills). In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of medication use, and distinction between controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use.

Also known as: inhaled corticosteroid

Inhaled corticosteroid (fluticasone)

Standard Asthma Discharge Instructions OTHER

Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)

Inhaled corticosteroid (fluticasone); Routine Asthma Care

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years of age
• child has asthma diagnosed by a doctor based on parental/caregiver report
• child is not already properly using an ICS or being discharged with an ICS

You may not qualify if:

• The child has previously participated in this study
• The child has major co-morbid disease of the heart or lungs (examples include cystic fibrosis, heart disease, muscular dystrophy and cerebral palsy with immobility. It does not include allergic rhinitis or a history of respiratory infections such as pneumonia or bronchiolitis.
• The child's parents/caregivers do not speak English
• The child is not going to be discharged from the emergency department (e.g. hospitalization)

Sponsors & Collaborators

• Rhode Island Hospital: lead
• American Lung Association: collaborator

Study Sites (1)

Rhode Island Hospital / Hasbro Children's Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Asthma; Emergencies

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Aris Garro
• Organization: Rhode Island Hospital and Brown University

arisgarro1@gmail.com

401-480-8682

Study Officials

• Aris C Garro, MD, MPH

  Brown University and Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 19, 2013
• Study Start: August 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: May 18, 2020
• Results First Posted: May 18, 2020

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data currently available on request
• Access Criteria: Requests will be reviewed by the study investigators for appropriateness

Locations

US (1)