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Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department (IRUSBUPR0045)

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ClinicalTrials.gov Identifier: NCT00388739
Recruitment Status : Withdrawn (Different study was designed)
First Posted : October 17, 2006
Last Update Posted : July 20, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Andrea Cruz, Baylor College of Medicine

Brief Summary:

Hypothesis: Initiating chronic management treatment plans in conjunction with an asthma educational intervention in the pediatric Emergency Department (ED) with anti-inflammatory medication will result in an improvement of ED revisits (and unscheduled return visits). Chronic management intitiation in conjunction with an asthma educational intervention in the pediatric ED with anti-inflammatory medication will also result in improved Quality of Life measure.

Specific aims: 1. To demonstrate that the initiation controller medication therapy in conjunction with asthma education will result in:

  1. Decreased return ED visits (or unscheduled primary care physician visits) as compared to a control group over a 12 month period
  2. Improved Quality of Life as measured by Bukstein's ITG Quality of Life measure.

    2. To describe the relationship of the initiation of controller medication therapy in conjunction with asthma education with well child visits, missed school/daycare days and behavioral capabilities.

    Objective: To determine the impact of beginning chronic asthma medication regimens after an educational intervention in the ED in pediatric patients 1-18 years of age with mild to moderate persistent asthma.

    Long-term goal/purpose: To demonstrate the success of a model of care that utilizes the emergency department physician to initiate National Asthma Education and Prevention Program (NAEPP) guided chronic asthma therapy in children 1-18 years of age. This model will attempt to bridge the gap in initiation of chronic asthma therapy currently left by a failure of both emergency department and primary care physicians.


Condition or disease Intervention/treatment Phase
Asthma Drug: Intervention: Budesonide Drug: Usual care: albuterol + systemic steroids Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: This was a health outcomes intervention trial that utilized a randomized clinical trial (non-placebo controlled) with two separate arms. All patients received steroids and bronchodilators, but then were randomized to either no intervention or to Pulmicort respules
Masking: None (Open Label)
Masking Description: patients will be randomized to a control and intervention group. Randomization will occur utilizing assignment by a randomized number table. The randomization scheme will then be packaged into sealed envelopes concealed to the educational interventionist at the time of enrollment. Once the patient is enrolled, the interventionist will open the sealed envelope revealing assignment to intervention or control.
Primary Purpose: Treatment
Official Title: Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department
Estimated Study Start Date : November 1, 2006
Estimated Primary Completion Date : November 1, 2006
Estimated Study Completion Date : November 1, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Usual care
Systemic steroids (4 days of prednisone, 1mg/kg/dose to a maximum of 40 mg/dose to be given twice a day). Subjects will also receive standardized discharge medication instructions for using albuterol nebulizer treatments: they will receive a prescription for 2.5mg of albuterol in 3cc Normal Saline for aerosol use via compressor every 3 times a day as a chronic care regimen if they are either in the treatment arm and 1-5 years of age or if they are in the control group and already own a nebulization compressor. Children in the control group that do not own a nebulization compressor will be given a prescription for an albuterol MDI with mask and spacer with instructions to deliver 2 puffs (90mcg per actuation) 3 times a day as a standard chronic care regimen. Instructions to follow-up with their primary care physician in 3-5 days (as is standard care practice) will be given at discharge for patients in the control or treatment arm.
Drug: Usual care: albuterol + systemic steroids
All children (control and treatment arm) will be given a burst dose of steroids (4 days of prednisone, 1mg/kg/dose to a maximum of 40 mg/dose to be given twice a day) at discharge from the ED. All children 1-5 years of age will also receive standardized discharge medication instructions for using albuterol nebulizer treatments: they will receive a prescription for 2.5mg of albuterol in 3cc Normal Saline for aerosol use via compressor every 3 times a day as a chronic care regimen if they are either in the treatment arm and 1-5 years of age or if they are in the control group and already own a nebulization compressor.
Other Name: Albuterol + prednisolone

Experimental: Usual care + 6 months of inhaled steroids
In addition to the usual care described above, patients randomized to the intervention/experimental arm will also be given a one month supply as well as a prescription (for a 6 month supply) for Budesonide respules (children with mild persistent disease will receive 0.25 mg bid whereas children with moderate or severe persistent disease will receive 0.5 mg bid).
Drug: Intervention: Budesonide
Patients 1-5 years of age who are randomly assigned to the treatment arm will be given a one month supply as well as a prescription (for a 6 month supply) for Pulmicort respules (children with mild persistent disease will receive 0.25 mg bid whereas children with moderate or severe persistent disease will receive 0.5 mg bid).
Other Name: Pulmicort

Drug: Usual care: albuterol + systemic steroids
All children (control and treatment arm) will be given a burst dose of steroids (4 days of prednisone, 1mg/kg/dose to a maximum of 40 mg/dose to be given twice a day) at discharge from the ED. All children 1-5 years of age will also receive standardized discharge medication instructions for using albuterol nebulizer treatments: they will receive a prescription for 2.5mg of albuterol in 3cc Normal Saline for aerosol use via compressor every 3 times a day as a chronic care regimen if they are either in the treatment arm and 1-5 years of age or if they are in the control group and already own a nebulization compressor.
Other Name: Albuterol + prednisolone




Primary Outcome Measures :
  1. ED and primary care provider utilization [ Time Frame: 12 months ]
    Decreased return ED visits (or unscheduled primary care physician visits) as compared to a control group over a 12 month period will be measured by comparisons of total number of ED visits (and unscheduled PCP visits) in each group


Secondary Outcome Measures :
  1. Improved Quality of Life as measured by Bukstein's ITG will utilize the scoring system developed by Bukstein to evaluate individual parameters as well as aggregate scores in the control and intervention group at each of the 3 month intervals. Significan [ Time Frame: Measured at 3, 9, and 12 months ]
    Bukstein's ITG is a validated score to evaluate individual parameters as well as aggregate scores in the control and intervention group.



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The enrollees involved must be a child who is 1-18 years of age, with a diagnosis of persistent asthma or reactive airway disease and no other cardiovascular or pulmonary disease not currently on the NAEPP recommended chronic care regimen for controller medication therapy.

Exclusion Criteria:

  • Patients without a physician's confirmed diagnosis of asthma. Children with concurrent cardiovascular or pulmonary disease. Patients will also be excluded if they do not speak English or Spanish as their primary language.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388739


Locations
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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
AstraZeneca
Investigators
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Principal Investigator: Andrea T Cruz, MD, MPH Baylor College of Medicine
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Responsible Party: Andrea Cruz, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00388739    
Other Study ID Numbers: H-19489
First Posted: October 17, 2006    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Keywords provided by Andrea Cruz, Baylor College of Medicine:
Pediatric Asthma
Pulmicort
TEDAS ED
Acute exacerbation of asthma
Chronic asthma
Additional relevant MeSH terms:
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Asthma
Emergencies
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Prednisolone
Budesonide
Albuterol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists