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Inhaled Steroids for Pediatric Asthma at Pediatric Emergency Medicine Discharge

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ClinicalTrials.gov Identifier: NCT03369847
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
New York City Health and Hospitals Corporation

Tracking Information
First Submitted Date  ICMJE December 6, 2017
First Posted Date  ICMJE December 12, 2017
Last Update Posted Date February 1, 2019
Actual Study Start Date  ICMJE September 10, 2017
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03369847 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2017)
  • Hospital admission [ Time Frame: 28 days after index emergency department visit ]
    Hospital admission
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhaled Steroids for Pediatric Asthma at Pediatric Emergency Medicine Discharge
Official Title  ICMJE Initiating Inhaled Corticosteroid Therapy at Discharge From the Pediatric Emergency Department to Prevent Asthma Relapse: A Randomized Control Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma
  • Pediatric ALL
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: budesonide, beclomethasone
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 6, 2017)
820
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Tian Liang, MD 516 808 8455 LIANGT1@NYCHHC.ORG
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03369847
Other Study ID Numbers  ICMJE 17-10-161-202(HHC)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party New York City Health and Hospitals Corporation
Study Sponsor  ICMJE New York City Health and Hospitals Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account New York City Health and Hospitals Corporation
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP