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
|Condition or disease||Intervention/treatment||Phase|
|Asthma Pediatric ALL||Drug: budesonide, beclomethasone||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||820 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||May 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: Inhaled Corticosteroids
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.
- 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
- 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
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
|Contact: Tian Liang, MD||516 808 8455||LIANGT1@NYCHHC.ORG|
|United States, New York|
|Kings County Hospital Center||Recruiting|
|Brooklyn, New York, United States, 11203|
|Contact: Tian Liang, MD 516-808-8455 LIANGT1@NYCHHC.ORG|