Clinical trial · Interventional
Inhaled Steroids for Pediatric Asthma at Pediatric Emergency Medicine Discharge
Initiating Inhaled Corticosteroid Therapy at Discharge From the Pediatric Emergency Department to Prevent Asthma Relapse: A Randomized Control Trial
NCT03369847CI-TRIAL-00039553completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asthma | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| budesonide, beclomethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Inhaled Corticosteroids
- description
- * 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
- interventionNames
- Drug: budesonide, beclomethasone
- type
- NO_INTERVENTION
- label
- Standard Care
- description
- 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 outcomes (1)
- measure
- Asthma exacerbation relapse
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (22)
- BACKGROUNDNational Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043. PMID 17983880
- BACKGROUNDMcCarren M, McDermott MF, Zalenski RJ, Jovanovic B, Marder D, Murphy DG, Kampe LM, Misiewicz VM, Rydman RJ. Prediction of relapse within eight weeks after an acute asthma exacerbation in adults. J Clin Epidemiol. 1998 Feb;51(2):107-18. doi: 10.1016/s0895-4356(97)00246-1. PMID 9474071
- BACKGROUNDCloutier MM, Hall CB, Wakefield DB, Bailit H. Use of asthma guidelines by primary care providers to reduce hospitalizations and emergency department visits in poor, minority, urban children. J Pediatr. 2005 May;146(5):591-7. doi: 10.1016/j.jpeds.2004.12.017. PMID 15870660
- BACKGROUNDNavaratnam P, Jayawant SS, Pedersen CA, Balkrishnan R. Physician adherence to the national asthma prescribing guidelines: evidence from national outpatient survey data in the United States. Ann Allergy Asthma Immunol. 2008 Mar;100(3):216-21. doi: 10.1016/S1081-1206(10)60445-0. PMID 18426140
- BACKGROUNDSingh AK, Woodruff PG, Ritz RH, Mitchell D, Camargo CA Jr. Inhaled corticosteroids for asthma: are ED visits a missed opportunity for prevention? Am J Emerg Med. 1999 Mar;17(2):144-7. doi: 10.1016/s0735-6757(99)90047-5. PMID 10102313
- BACKGROUNDZorc JJ, Chew A, Allen JL, Shaw K. Beliefs and barriers to follow-up after an emergency department asthma visit: a randomized trial. Pediatrics. 2009 Oct;124(4):1135-42. doi: 10.1542/peds.2008-3352. Epub 2009 Sep 28. PMID 19786448
- BACKGROUNDAndrews AL, Teufel RJ 2nd, Basco WT Jr. Initiating inhaled steroid treatment for children with asthma in the emergency room: current reported prescribing rates and frequently cited barriers. Pediatr Emerg Care. 2013 Sep;29(9):957-62. doi: 10.1097/PEC.0b013e3182a219d0.