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
Results First Received: May 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Asthma
Interventions: Other: ICS Prescription + Standard Asthma ED Discharge Therapy
Other: Standard Asthma ED Discharge Therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were screened for enrollment at the Children's Hospital of Philadelphia Emergency Department (ED) between 2006 to 2009. Of the 75,000 annual ED visits in the Children's Hospital of Philadelphia ED per year, more than 6,000 of these visit represent patients with acute asthma.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
152 participants were enrolled and randomized between 2006 and 2009 in the Children's Hospital of Philadelphia Emergency Department.

Reporting Groups
  Description
Standard Asthma ED Discharge Therapy Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and were provided a home nebulizer if needed.
ICS Prescription + Standard Asthma ED Discharge Therapy

Subjects were 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


Participant Flow:   Overall Study
    Standard Asthma ED Discharge Therapy     ICS Prescription + Standard Asthma ED Discharge Therapy  
STARTED     78     74  
COMPLETED     57     48  
NOT COMPLETED     21     26  
Lost to Follow-up                 21                 26  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Asthma ED Discharge Therapy Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and are provided a home nebulizer if needed.
ICS Prescription + Standard ED Discharge Therapy

Subjects were 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

Total Total of all reporting groups

Baseline Measures
    Standard Asthma ED Discharge Therapy     ICS Prescription + Standard ED Discharge Therapy     Total  
Number of Participants  
[units: participants]
  78     74     152  
Age  
[units: participants]
     
<=18 years     78     74     152  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  4.5  (3.1)     5.5  (4.8)     5.0  (4.0)  
Gender  
[units: participants]
     
Female     30     36     66  
Male     48     38     86  
Region of Enrollment  
[units: participants]
     
United States     78     74     152  



  Outcome Measures
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1.  Primary:   Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician)   [ Time Frame: 2 months ]

2.  Secondary:   Asthma-related Quality of Life   [ Time Frame: 2 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Esther Sampayo MD MPH
Organization: CHOP
phone: 215-590-1944
e-mail: sampayo@email.chop.edu


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