Inhaled Steroids for Pediatric Asthma at Pediatric Emergency Medicine Discharge

Sponsor

New York City Health and Hospitals Corporation (Other)

Overall Status

Completed

CT.gov ID

NCT03369847

Collaborator

(none)

Enrollment

Location

Arms

21.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Sep 10, 2017

Actual Primary Completion Date :

May 30, 2019

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

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 Names: 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.

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 Names:

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.

Outcome Measures

Primary Outcome Measures

Asthma exacerbation relapse [28 days after index emergency department visit]
Emergency department/urgent care visit or unscheduled primary care doctor visit for asthma symptoms

Secondary Outcome Measures

Hospital admission [28 days after index emergency department visit]
Hospital admission
Change in Asthma control [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 [28 days after index emergency department visit]
If prescribed an inhaled corticosteroid, defined as correct use of asthma controller medications on 80% of days

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.