Inhaled Steroids for Pediatric Asthma at Pediatric Emergency Medicine Discharge

NCT03369847 | Completed Phase 4 FDA Drug

• 1 other identifier: 17-10-161-202(HHC)
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Pediatric ALL

Keywords

inhaled corticosteroids; budesonide; beclomethasone

Outcome Measures

Primary Outcomes (1)

• Asthma exacerbation relapse

  Emergency department/urgent care visit or unscheduled primary care doctor visit for asthma symptoms

  28 days after index emergency department visit

Secondary Outcomes (3)

• Hospital admission

  28 days after index emergency department visit

• Change in Asthma control

  28 days after index emergency department visit

• Medication compliance

  28 days after index emergency department visit

Study Arms (2)

Inhaled Corticosteroids

EXPERIMENTAL

* 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

Standard Care

NO INTERVENTION

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.

Interventions

budesonide, beclomethasone DRUG

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.

Also known as: Pulmicort, QVAR

Inhaled Corticosteroids

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Received asthma controller medications within four weeks prior to presentation
• Allergy to intervention asthma controller medications.

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

Kings County Hospital Center

Brooklyn, New York, 11203, United States

Location

Related Publications (22)

• National 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 BACKGROUND

• McCarren 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.

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• Cloutier 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.

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  PMID: 18426140 BACKGROUND

• Singh 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 BACKGROUND

• Zorc 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 BACKGROUND

• Andrews 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.

  PMID: 23974712 BACKGROUND

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  PMID: 16187464 BACKGROUND

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  PMID: 16510663 BACKGROUND

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  PMID: 10367823 BACKGROUND

• Sin DD, Man SF. Low-dose inhaled corticosteroid therapy and risk of emergency department visits for asthma. Arch Intern Med. 2002 Jul 22;162(14):1591-5. doi: 10.1001/archinte.162.14.1591.

  PMID: 12123402 BACKGROUND

• Sung L, Osmond MH, Klassen TP. Randomized, controlled trial of inhaled budesonide as an adjunct to oral prednisone in acute asthma. Acad Emerg Med. 1998 Mar;5(3):209-13. doi: 10.1111/j.1553-2712.1998.tb02614.x.

  PMID: 9523927 BACKGROUND

• Andrews AL, Teufel RJ 2nd, Basco WT Jr, Simpson KN. A cost-effectiveness analysis of inhaled corticosteroid delivery for children with asthma in the emergency department. J Pediatr. 2012 Nov;161(5):903-7. doi: 10.1016/j.jpeds.2012.05.015. Epub 2012 Jun 18.

  PMID: 22717219 BACKGROUND

• Lehman HK, Lillis KA, Shaha SH, Augustine M, Ballow M. Initiation of maintenance antiinflammatory medication in asthmatic children in a pediatric emergency department. Pediatrics. 2006 Dec;118(6):2394-401. doi: 10.1542/peds.2006-0871.

  PMID: 17142524 BACKGROUND

• Brenner BE, Chavda KK, Camargo CA Jr. Randomized trial of inhaled flunisolide versus placebo among asthmatic patients discharged from the emergency department. Ann Emerg Med. 2000 Nov;36(5):417-26. doi: 10.1067/mem.2000.110824.

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  PMID: 23235590 BACKGROUND

• Topal E, Gucenmez OA, Harmanci K, Arga M, Derinoz O, Turktas I. Potential predictors of relapse after treatment of asthma exacerbations in children. Ann Allergy Asthma Immunol. 2014 Apr;112(4):361-4. doi: 10.1016/j.anai.2014.01.025. Epub 2014 Feb 28.

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  PMID: 11029352 BACKGROUND

• Sampayo EM, Chew A, Zorc JJ. Make an M-PACT on asthma: rapid identification of persistent asthma symptoms in a pediatric emergency department. Pediatr Emerg Care. 2010 Jan;26(1):1-5. doi: 10.1097/PEC.0b013e3181c32e9d.

  PMID: 20042916 BACKGROUND

• Gorelick MH, Stevens MW, Schultz TR, Scribano PV. Performance of a novel clinical score, the Pediatric Asthma Severity Score (PASS), in the evaluation of acute asthma. Acad Emerg Med. 2004 Jan;11(1):10-8. doi: 10.1197/j.aem.2003.07.015.

  PMID: 14709423 BACKGROUND

• Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.

  PMID: 16079372 BACKGROUND

MeSH Terms

Conditions

Asthma; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Budesonide; Beclomethasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Steroids, Chlorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 12, 2017
• Study Start: September 10, 2017
• Primary Completion: May 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

US (1)