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Inhaled Steroids for Pediatric Asthma at Pediatric Emergency Medicine Discharge

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ClinicalTrials.gov Identifier: NCT03369847
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
New York City Health and Hospitals Corporation

Brief Summary:
This study evaluates the initiation of inhaled corticosteroids upon discharge from the pediatric emergency room in children under 18 presenting with asthma exacerbation. Half of the patients will receive a prescription for inhaled corticosteroids in addition to standard care, and half of the patients will receive standard card alone.

Condition or disease Intervention/treatment Phase
Asthma Pediatric ALL Drug: budesonide, beclomethasone Phase 4

Detailed Description:

The primary objective is to determine the effect of prescribing inhaled corticosteroids in addition to short acting beta agonists and oral corticosteroids (if indicated) from the Pediatric Emergency Department (PED) on relapse rates within 28 days. Secondary objectives include the effect of this intervention on hospitalization rates and asthma quality of life within the study period.

Selection criteria include patients aged ≤18 years presenting with a chief complaint consistent with asthma exacerbation with previous diagnosis of asthma by a physician OR one major in the Asthma Predictive Index (API) with two prior episodes of wheezing in the past year. Children who received oral corticosteroids as part of treatment during this visit for acute asthma exacerbation and deemed well enough after interventions to be discharged by the treating physician will be approached for enrollment. Exclusion criteria include patients who received asthma controller medications within four weeks prior to presentation or an allergy to intervention asthma controller mediations.

Patients will be randomized using a random number generator to the intervention group, or standard care (control) group in a 1:1 ratio. Patients assigned to the intervention group will be subject to initiation of an asthma controller medication upon discharge. The intervention group will receive a one-month supply of a low-dose inhaled corticosteroid from the PED. Patients <5 years of age or patients who prefer nebulized medications will receive a one month supply of low dose Pulmicort (budesonide) solution 0.25mg/respule to be given twice a day via nebulizer. Patients ≥5 years of age will receive one low dose QVAR (Beclometasone dipropionate) metered-dose inhaler (MDI) 40mcg/puff with instructions to take it two puffs twice a day with spacer. Patients allocated to the control group will not receive an asthma controller medication from the PED. Both groups will receive prescriptions for oral corticosteroids as per standard treatment and inhaled albuterol. The Mini Pediatric Asthma Control Tool (MPACT), a validated questionnaire used to rapidly identify persistent asthma symptoms in the PED will also be administered prior to discharge to assess for persistent asthma symptoms.

Patients will be followed up with a telephone call at 28 days to collect outcome data. Additional attempts will be made at 29 and 30 days post-discharge if initial attempts at contact are unsuccessful. Primary and secondary outcomes will be assessed during this call. The caller will not be blinded to group assignment. Asthma relapse rates, hospital admission rates, and medication compliance will be assessed during this follow up call. In addition, the Mini Pediatric Asthma Control Tool will be re-administered to assess change in asthma control.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initiating Inhaled Corticosteroid Therapy at Discharge From the Pediatric Emergency Department to Prevent Asthma Relapse: A Randomized Control Trial
Actual Study Start Date : September 10, 2017
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : June 30, 2019


Arm Intervention/treatment
Experimental: Inhaled Corticosteroids
  • Patients under 5 years of age will receive low dose budesonide solution 0.25mg/respule to be given twice a day via nebulizer x 28 days.
  • Patients 5 years and older will receive one beclomethasone metered-dose inhaler (MDI) 40mcg/puff two puffs twice a day via spacer x 28 days
Drug: budesonide, beclomethasone
The inhaled corticosteroids we are using for this study are budesonide nebulized solution and beclomethasone metered-dose inhaler. Low-doses for these medications are 0.5mg/day for budesonide and 160 mcg/day for beclomethasone. Patients under 5 years of age will receive low dose budesonide solution 0.25mg/respule to be given twice a day via nebulizer. Budesonide is FDA approved for children under 5 years of age. Patients 5 years and older will receive one beclomethasone metered-dose inhaler (MDI) 40mcg/puff two puffs twice a day via spacer. Beclomethasone is FDA approved for children 5 years and older.
Other Name: Pulmicort, QVAR

No Intervention: Standard Care
Patients allocated to this group will not receive an asthma controller medication from the emergency department. The intervention group will receive prescriptions for inhaled albuterol and oral corticosteroids as per standard treatment.



Primary Outcome Measures :
  1. Asthma exacerbation relapse [ Time Frame: 28 days after index emergency department visit ]
    Emergency department/urgent care visit or unscheduled primary care doctor visit for asthma symptoms


Secondary Outcome Measures :
  1. Hospital admission [ Time Frame: 28 days after index emergency department visit ]
    Hospital admission

  2. Change in Asthma control [ Time Frame: 28 days after index emergency department visit ]
    Intermittent vs. persistent symptoms after the study period via repeat of the Mini Pediatric Asthma Control Tool (MPACT) score

  3. Medication compliance [ Time Frame: 28 days after index emergency department visit ]
    If prescribed an inhaled corticosteroid, defined as correct use of asthma controller medications on 80% of days



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chief complaint consistent with asthma exacerbation
  • Previous diagnosis of asthma by a physician OR one major in the Asthma Predictive Index (API) with two prior episodes of wheezing in the past year.
  • Major criteria in the API: parent with asthma, patient with eczema, evidence of sensitization to allergens in the air
  • Received oral corticosteroids as part of treatment during this visit for acute asthma exacerbation.
  • Deemed well enough after interventions to be discharged by the treating physician.
  • If <5 years of age, possession of nebulizer machine at home.

Exclusion Criteria:

  • Received asthma controller medications within four weeks prior to presentation
  • Allergy to intervention asthma controller medications.

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): NCT03369847


Locations
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United States, New York
Kings County Hospital Center
Brooklyn, New York, United States, 11203
Sponsors and Collaborators
New York City Health and Hospitals Corporation

Publications:

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Responsible Party: New York City Health and Hospitals Corporation
ClinicalTrials.gov Identifier: NCT03369847     History of Changes
Other Study ID Numbers: 17-10-161-202(HHC)
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by New York City Health and Hospitals Corporation:
inhaled corticosteroids
budesonide
beclomethasone
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
Budesonide
Beclomethasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists