Inhaled Steroids for Pediatric Asthma at Pediatric Emergency Medicine Discharge
| Status: | Recruiting |
|---|---|
| Conditions: | Asthma, Hospital |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 2/3/2019 |
| Start Date: | September 10, 2017 |
| End Date: | June 30, 2019 |
| Contact: | Tian Liang, MD |
| Email: | LIANGT1@NYCHHC.ORG |
| Phone: | 516 808 8455 |
Initiating Inhaled Corticosteroid Therapy at Discharge From the Pediatric Emergency Department to Prevent Asthma Relapse: A Randomized Control Trial
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.
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.
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.
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.
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.
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